ID

17469

Descripción

An open label, dose titration study of sevelamer carbonate tablets dosed three times a day in hyperphosphatemic chronic kidney disease patients not on dialysis Name of Sponsor: Genzyme Europe BV Country: Netherlands https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A

Link

https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A

Palabras clave

Versiones (3)
  1. 13/9/16 13/9/16 -
  2. 13/9/16 13/9/16 -
  3. 16/9/16 16/9/16 -
Subido en

16 de septiembre de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

Inglés

Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 formularios  
Patient administration
Descripción

Patient administration

Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Patient ID Number
Descripción

Patient ID Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Is the Patient a man or woman 18 years of age or older?
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. If the patient is currently taking phosphate binder(s) are they willing to stop this and enter a 2 week washout period?
Descripción

concomitant use of phosphate binders

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0357221
3. Is the patient willing to avoid any intentional changes in diet such as fasting or dieting?
Descripción

fasting or dieting

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C2945766
4. If the patient is currently not taking a phosphate binder, does the patient have a Serum phosphorus measurement of >=5.5mg/dL (1.76 mmol/L) at Screening? (If taking a phosphate binder(s) at Screening, please tick NA)
Descripción

Serum phosphorus measurement

Tipo de datos

integer

Alias
UMLS CUI [1]
C0202178
5. Does the patient have the following central laboratory measurements: a) 25-hydroxyvitamin-D >=10 ng/mL b) iPTH <=800 pg/mL
Descripción

hydroxyvitamin D and iPTH

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0535968
UMLS CUI [2]
C0202159
6. Is the patient willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study?
Descripción

compliant to sevelamer carbonate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1721288
7. Is the patient willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons?
Descripción

stable doses

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0042866
UMLS CUI [1,3]
C1337242
8. Is the patient willing and able to avoid antacids and phosphate binders containing aluminium, magnesium, calcium or lanthanum for the duration of the study, except for safety reasons?
Descripción

contact to aluminium, magnesium, calcium or lanthanum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002367
UMLS CUI [2]
C0006675
UMLS CUI [3]
C0024467
UMLS CUI [4]
C0023031
9. If female and of childbearing potential (pre-menopausal and not surgically steril), is the patient willing to use an effective contraceptive method throughout study, which includes barrier methods, Hormones, or IUDs?
Descripción

contraception

Tipo de datos

integer

Alias
UMLS CUI [1]
C0700589
10. Is the patient expected not to initiate dialysis for the duration of this study?
Descripción

dialysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011946
11. Is the patient considered compliant with phosphate binders (if applicable)?
Descripción

compliant to phosphate binders

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C4020599
12. Is the patient willing and able to provide informed consent?
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
13. Has the patient not participated in any other investigational drug studies within 30 days prior to enrollment?
Descripción

study participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
14. Does the patient have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel?
Descripción

study compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion criteria
Descripción

Exclusion criteria

Alias
UMLS CUI-1
C0680251
1. Does the patient have active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders?
Descripción

bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021843
UMLS CUI [2]
C0011168
UMLS CUI [3]
C0011168
UMLS CUI [4,1]
C0854121
UMLS CUI [4,2]
C0205082
2. Does the patient have an active Ethanol or drug abuse, excluding tobacco use?
Descripción

active substance abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
3. Does the patient use anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders?
Descripción

use of anti-arrhythmic or anti-seizure drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0003286
4. In the opinion of the investigator, does the patient have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition?
Descripción

unstable comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
5. If female, is the patient pregnant or breast feeding?
Descripción

pregnant or breast-feeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
6. Does the patient have any evidence of active malignancy except for basal cell carcinoma of the skin?
Descripción

malignant neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
7. Is the patient unable to comply with the requirements of the study?
Descripción

study protocol compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1321605
8. Does the patient have a known hypersensitivity to sevelamer or any constituents of the study drug?
Descripción

hypersensitivity to study drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C071805
9. Does the patient have any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study?
Descripción

comorbidity prohibiting study inclusion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
Date Informed Consent signed
Descripción

date informed consent signed

Tipo de datos

date

Alias
UMLS CUI [1]
C2985782
Patient met all enrollment criteria?
Descripción

Patient met all enrollment criteria?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1302261
Patient demographics
Descripción

Patient demographics

Alias
UMLS CUI-1
C1955348
Date of birth
Descripción

date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Ethnicity:
Descripción

Ethnicity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015031
if previous answered with other, please specify:
Descripción

if previous answered with other, please specify

Tipo de datos

text

Alias
UMLS CUI [1]
C0015031
Sex:
Descripción

sex

Tipo de datos

integer

Alias
UMLS CUI [1]
C0079399
Smoker?
Descripción

Smoker

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
Diabetes mellitus?
Descripción

Diabetes mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
Vital signs
Descripción

Vital signs

Alias
UMLS CUI-1
C0518766
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiratory Rate
Descripción

Respiratory Rate

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Weight and Height
Descripción

Weight and Height

Alias
UMLS CUI-1
C0005910
UMLS CUI-3
C0005890
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Descripción

Height

Tipo de datos

float

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Medical/Surgical History
Descripción

Medical/Surgical History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0455610
Body System
Descripción

Body System

Tipo de datos

text

Alias
UMLS CUI [1]
C0460002
History?
Descripción

medical history

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262926
Current:
Descripción

if yes (@medical history), speficy in appropriate description field

Tipo de datos

text

Alias
UMLS CUI [1]
C3827351
Non-current:
Descripción

if yes (@medical history), speficy in appropriate description field:

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3645583
Renal history
Descripción

Renal history

Alias
UMLS CUI-1
C2136530
1. Primary cause of ESRD
Descripción

Primary cause of ESRD

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2316810
UMLS CUI [1,2]
C0015127
if previous item answered with other, please specify
Descripción

if previous item answered with other, please specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2316810
UMLS CUI [1,2]
C0015127
3. Has the patient ever had a kidney transplant?
Descripción

kidney transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022671
4. Is the patient currently on Vitamin D?
Descripción

currently on Vitamin D

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2936842
5. Has the aptient had a parathyroidectomy?
Descripción

parathyroidectomy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079989
6. Patients last three Serum Creatinine measurements: No.1 of 3
Descripción

serum creatinine measurement No. 1 of 3

Tipo de datos

integer

Unidades de medida
  • umol/L
Alias
UMLS CUI [1]
C0201976
umol/L
6. Patients last three Serum Creatinine measurements: No.2 of 3
Descripción

serum creatinine measurement No. 2 of 3

Tipo de datos

integer

Unidades de medida
  • umol/L
Alias
UMLS CUI [1]
C0201976
umol/L
6. Patients last three Serum Creatinine measurements: No.3 of 3
Descripción

serum creatinine measurement No. 3 of 3

Tipo de datos

integer

Unidades de medida
  • umol/L
Alias
UMLS CUI [1]
C0201976
umol/L
2. Type of Current Phosphate Binders:
Descripción

2. Type of Current Phosphate Binders:

Alias
UMLS CUI-1
C4020599
type of current phosphate binders applicable?
Descripción

type of current phosphate binders applicable?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4020599
UMLS CUI [1,2]
C1706839
Calcium Carbonate
Descripción

Calcium Carbonate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006681
Calcium Carbonate (Total daily dose)
Descripción

Calcium Carbonate (Total daily dose)

Tipo de datos

float

Unidades de medida
  • mg/day
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0006681
mg/day
Calcium Acetate
Descripción

Calcium Acetate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0717537
Calcium Acetate (Total daily dose)
Descripción

Calcium Acetate (Total daily dose)

Tipo de datos

float

Unidades de medida
  • mg/day
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0717537
mg/day
Aluminium
Descripción

Aluminium

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002367
Aluminium (Total daily dose)
Descripción

Aluminium (Total daily dose)

Tipo de datos

float

Unidades de medida
  • mg/day
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0002367
mg/day
Renagel
Descripción

Renagel

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0526563
RenaGel (Total daily dose)
Descripción

RenaGel (Total daily dose)

Tipo de datos

float

Unidades de medida
  • mg/day
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0526563
mg/day
Lanthanum
Descripción

Lanthanum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0768119
Lanthanum (Total daily dose)
Descripción

Lanthanum (Total daily dose)

Tipo de datos

float

Unidades de medida
  • mg/day
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0768119
mg/day
Other, specify:
Descripción

other phosphate binder

Tipo de datos

text

Alias
UMLS CUI [1]
C2267031
Other phosphate binder (Total daily dose)
Descripción

Other phosphate binder (Total daily dose)

Tipo de datos

float

Unidades de medida
  • mg/day
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C2267031
mg/day
Physical Exam
Descripción

Physical Exam

Alias
UMLS CUI-1
C0031809
Date:
Descripción

Date of physical exam

Tipo de datos

date

Alias
UMLS CUI [1]
C2826643
1. General Appearance
Descripción

General Appearance

Tipo de datos

integer

Alias
UMLS CUI [1]
C1148438
if abnormal, explain:
Descripción

General appearance abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C1704258
2. Skin
Descripción

physical examination of skin

Tipo de datos

integer

Alias
UMLS CUI [1]
C0436149
if abnormal, explain:
Descripción

skin abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0436149
3. HEENT
Descripción

physical examination of HEENT

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1512338
if abnormal, explain:
Descripción

HEENT abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1512338
4. Lymph Nodes
Descripción

physical examination of lymph nodes

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
if abnormal, explain:
Descripción

Lymph nodes abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0024204
5. Heart
Descripción

physical examination of heart

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018787
if abnormal, explain:
Descripción

heart abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0018787
6. Lungs
Descripción

physical examination of lungs

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
if abnormal, explain:
Descripción

lung abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0024109
7. Breasts
Descripción

physical examination of breast

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0006141
if abnormal, explain:
Descripción

breasts abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0006141
8. Abdomen
Descripción

physical examination of abdomen

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
if abnormal, explain:
Descripción

abdomen abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0000726
9. External Genitalia
Descripción

physical examination of external genitalia

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0227605
if abnormal, explain:
Descripción

external genitalia abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0227605
10. Pelvic
Descripción

physical examination of pelvis

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
if abnormal, explain:
Descripción

pelvis abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0030797
11. Rectal
Descripción

rectal examination

Tipo de datos

integer

Alias
UMLS CUI [1]
C0199900
if abnormal, explain:
Descripción

rectum abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0199900
12. Extremities/Joints
Descripción

physical examination of Extremities/Joints

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015385
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0022417
if abnormal, explain:
Descripción

extremities/joints abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0015385
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0022417
13. Neurological
Descripción

neurological examination

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027853
if abnormal, explain:
Descripción

neurological examination abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0027853
14. Mental Status
Descripción

mental status examination

Tipo de datos

integer

Alias
UMLS CUI [1]
C0278060
if abnormal, explain:
Descripción

mental status examination abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0278060
Laboratory Evaluations (Central Lab)
Descripción

Laboratory Evaluations (Central Lab)

Alias
UMLS CUI-1
C0022877
Chemistry Sample Date
Descripción

ChemistryLabCollectedDate

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0007996
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0011008
Hematology Sample Date
Descripción

Hematology Sample Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Serum Beta-hCG Sample Date
Descripción

Serum beta-hcg

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0106132
UMLS CUI [1,3]
C0011008
Serum beta-hCG
Descripción

Serum beta-hCG finding

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0106132
Concomitant Medication
Descripción

Concomitant Medication

Are there any prior medication taken within the last 30 days?
Descripción

If yes, please record on Concomitant Medications on page 21.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Washout/Drug Dispensing
Descripción

Washout/Drug Dispensing

Is the patient currently taking phosphate binder(s)?
Descripción

If yes, please instruct patient to discontinue phosphate binder treatment for two weeks. If no, please record the visit date and number of tablets dispensed on the Baseline record on the compliance page 19, an continue with visit 2 (day 14).

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C2267031
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Similar models

Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient administration
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient ID Number
Item
Patient ID Number
integer
C2348585 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age
Item
1. Is the Patient a man or woman 18 years of age or older?
boolean
C0001779 (UMLS CUI [1])
Item
2. If the patient is currently taking phosphate binder(s) are they willing to stop this and enter a 2 week washout period?
integer
C2347852 (UMLS CUI [1,1])
C0357221 (UMLS CUI [1,2])
concomitant use of phosphate binders
Code List
2. If the patient is currently taking phosphate binder(s) are they willing to stop this and enter a 2 week washout period?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
fasting or dieting
Item
3. Is the patient willing to avoid any intentional changes in diet such as fasting or dieting?
boolean
C0015663 (UMLS CUI [1])
C2945766 (UMLS CUI [2])
Item
4. If the patient is currently not taking a phosphate binder, does the patient have a Serum phosphorus measurement of >=5.5mg/dL (1.76 mmol/L) at Screening? (If taking a phosphate binder(s) at Screening, please tick NA)
integer
C0202178 (UMLS CUI [1])
Serum phosphorus measurement
Code List
4. If the patient is currently not taking a phosphate binder, does the patient have a Serum phosphorus measurement of >=5.5mg/dL (1.76 mmol/L) at Screening? (If taking a phosphate binder(s) at Screening, please tick NA)
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
hydroxyvitamin D and iPTH
Item
5. Does the patient have the following central laboratory measurements: a) 25-hydroxyvitamin-D >=10 ng/mL b) iPTH <=800 pg/mL
boolean
C0535968 (UMLS CUI [1])
C0202159 (UMLS CUI [2])
compliant to sevelamer carbonate
Item
6. Is the patient willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study?
boolean
C1321605 (UMLS CUI [1,1])
C1721288 (UMLS CUI [1,2])
stable doses
Item
7. Is the patient willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons?
boolean
C0678766 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
C1337242 (UMLS CUI [1,3])
contact to aluminium, magnesium, calcium or lanthanum
Item
8. Is the patient willing and able to avoid antacids and phosphate binders containing aluminium, magnesium, calcium or lanthanum for the duration of the study, except for safety reasons?
boolean
C0002367 (UMLS CUI [1])
C0006675 (UMLS CUI [2])
C0024467 (UMLS CUI [3])
C0023031 (UMLS CUI [4])
Item
9. If female and of childbearing potential (pre-menopausal and not surgically steril), is the patient willing to use an effective contraceptive method throughout study, which includes barrier methods, Hormones, or IUDs?
integer
C0700589 (UMLS CUI [1])
contraception
Code List
9. If female and of childbearing potential (pre-menopausal and not surgically steril), is the patient willing to use an effective contraceptive method throughout study, which includes barrier methods, Hormones, or IUDs?
CL Item
Yes (1)
CL Item
No  (2)
CL Item
NA (3)
dialysis
Item
10. Is the patient expected not to initiate dialysis for the duration of this study?
boolean
C0011946 (UMLS CUI [1])
compliant to phosphate binders
Item
11. Is the patient considered compliant with phosphate binders (if applicable)?
boolean
C1321605 (UMLS CUI [1,1])
C4020599 (UMLS CUI [1,2])
informed consent
Item
12. Is the patient willing and able to provide informed consent?
boolean
C0021430 (UMLS CUI [1])
study participation status
Item
13. Has the patient not participated in any other investigational drug studies within 30 days prior to enrollment?
boolean
C2348568 (UMLS CUI [1])
study compliance
Item
14. Does the patient have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel?
boolean
C1321605 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders
Item
1. Does the patient have active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders?
boolean
C0021843 (UMLS CUI [1])
C0011168 (UMLS CUI [2])
C0011168 (UMLS CUI [3])
C0854121 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
active substance abuse
Item
2. Does the patient have an active Ethanol or drug abuse, excluding tobacco use?
boolean
C0038586 (UMLS CUI [1])
use of anti-arrhythmic or anti-seizure drugs
Item
3. Does the patient use anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders?
boolean
C0003195 (UMLS CUI [1,1])
C0003286 (UMLS CUI [1,2])
unstable comorbidity
Item
4. In the opinion of the investigator, does the patient have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition?
boolean
C0009488 (UMLS CUI [1])
pregnant or breast-feeding
Item
5. If female, is the patient pregnant or breast feeding?
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
malignant neoplasms
Item
6. Does the patient have any evidence of active malignancy except for basal cell carcinoma of the skin?
boolean
C0006826 (UMLS CUI [1])
study protocol compliance
Item
7. Is the patient unable to comply with the requirements of the study?
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
hypersensitivity to study drug
Item
8. Does the patient have a known hypersensitivity to sevelamer or any constituents of the study drug?
boolean
C0020517 (UMLS CUI [1,1])
C071805 (UMLS CUI [1,2])
comorbidity prohibiting study inclusion
Item
9. Does the patient have any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study?
boolean
C0009488 (UMLS CUI [1])
date informed consent signed
Item
Date Informed Consent signed
date
C2985782 (UMLS CUI [1])
Patient met all enrollment criteria?
Item
Patient met all enrollment criteria?
boolean
C1302261 (UMLS CUI [1])
Item Group
Patient demographics
C1955348 (UMLS CUI-1)
date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Ethnicity:
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity:
CL Item
Caucasian (1)
CL Item
Black (2)
CL Item
Hispanic (3)
CL Item
Asian (4)
CL Item
Other (5)
if previous answered with other, please specify
Item
if previous answered with other, please specify:
text
C0015031 (UMLS CUI [1])
Item
Sex:
integer
C0079399 (UMLS CUI [1])
sex
Code List
Sex:
CL Item
Male (1)
CL Item
Female (2)
Smoker
Item
Smoker?
boolean
C0543414 (UMLS CUI [1])
Diabetes mellitus
Item
Diabetes mellitus?
boolean
C0011849 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Respiratory Rate
Item
Respiratory Rate
integer
C0231832 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item Group
Weight and Height
C0005910 (UMLS CUI-1)
C0005890 (UMLS CUI-3)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item Group
Medical/Surgical History
C0262926 (UMLS CUI-1)
C0455610 (UMLS CUI-2)
Body System
Item
Body System
text
C0460002 (UMLS CUI [1])
medical history
Item
History?
boolean
C0262926 (UMLS CUI [1])
if yes (@medical history), speficy in appropriate description field
Item
Current:
text
C3827351 (UMLS CUI [1])
if yes (@medical history), speficy in appropriate description field:
Item
Non-current:
text
C0012634 (UMLS CUI [1,1])
C3645583 (UMLS CUI [1,2])
Item Group
Renal history
C2136530 (UMLS CUI-1)
Item
1. Primary cause of ESRD
integer
C2316810 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Primary cause of ESRD
Code List
1. Primary cause of ESRD
CL Item
Hypertension (1)
CL Item
Glomerulonephritis (2)
CL Item
Diabetes (3)
CL Item
Pyelonephritis (4)
CL Item
Polycystic Kidneys (5)
CL Item
Hydronephrosis (6)
CL Item
Interstitial Nephritis (7)
CL Item
Vasculitis (8)
CL Item
Congenital (9)
CL Item
Other, specify (next item) (10)
if previous item answered with other, please specify
Item
if previous item answered with other, please specify
text
C2316810 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
kidney transplant
Item
3. Has the patient ever had a kidney transplant?
boolean
C0022671 (UMLS CUI [1])
currently on Vitamin D
Item
4. Is the patient currently on Vitamin D?
boolean
C2936842 (UMLS CUI [1])
parathyroidectomy
Item
5. Has the aptient had a parathyroidectomy?
boolean
C0079989 (UMLS CUI [1])
serum creatinine measurement No. 1 of 3
Item
6. Patients last three Serum Creatinine measurements: No.1 of 3
integer
C0201976 (UMLS CUI [1])
serum creatinine measurement No. 2 of 3
Item
6. Patients last three Serum Creatinine measurements: No.2 of 3
integer
C0201976 (UMLS CUI [1])
serum creatinine measurement No. 3 of 3
Item
6. Patients last three Serum Creatinine measurements: No.3 of 3
integer
C0201976 (UMLS CUI [1])
Item Group
2. Type of Current Phosphate Binders:
C4020599 (UMLS CUI-1)
type of current phosphate binders applicable?
Item
type of current phosphate binders applicable?
boolean
C4020599 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Calcium Carbonate
Item
Calcium Carbonate
boolean
C0006681 (UMLS CUI [1])
Calcium Carbonate (Total daily dose)
Item
Calcium Carbonate (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0006681 (UMLS CUI [1,2])
Calcium Acetate
Item
Calcium Acetate
boolean
C0717537 (UMLS CUI [1])
Calcium Acetate (Total daily dose)
Item
Calcium Acetate (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0717537 (UMLS CUI [1,2])
Aluminium
Item
Aluminium
boolean
C0002367 (UMLS CUI [1])
Aluminium (Total daily dose)
Item
Aluminium (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0002367 (UMLS CUI [1,2])
Renagel
Item
Renagel
boolean
C0526563 (UMLS CUI [1])
RenaGel (Total daily dose)
Item
RenaGel (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0526563 (UMLS CUI [1,2])
Lanthanum
Item
Lanthanum
boolean
C0768119 (UMLS CUI [1])
Lanthanum (Total daily dose)
Item
Lanthanum (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0768119 (UMLS CUI [1,2])
other phosphate binder
Item
Other, specify:
text
C2267031 (UMLS CUI [1])
Other phosphate binder (Total daily dose)
Item
Other phosphate binder (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C2267031 (UMLS CUI [1,2])
Item Group
Physical Exam
C0031809 (UMLS CUI-1)
Date of physical exam
Item
Date:
date
C2826643 (UMLS CUI [1])
Item
1. General Appearance
integer
C1148438 (UMLS CUI [1])
General Appearance
Code List
1. General Appearance
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
General appearance abnormal
Item
if abnormal, explain:
text
C1148438 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
2. Skin
integer
C0436149 (UMLS CUI [1])
physical examination of skin
Code List
2. Skin
CL Item
Normal  (1)
CL Item
Abnormal  (2)
CL Item
Not Examined (3)
skin abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0436149 (UMLS CUI [1,2])
Item
3. HEENT
integer
C0031809 (UMLS CUI [1,1])
C1512338 (UMLS CUI [1,2])
physical examination of HEENT
Code List
3. HEENT
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
HEENT abnormal
Item
if abnormal, explain:
text
C0031809 (UMLS CUI [1,1])
C1512338 (UMLS CUI [1,2])
Item
4. Lymph Nodes
integer
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
physical examination of lymph nodes
Code List
4. Lymph Nodes
CL Item
Normal  (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
Lymph nodes abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Item
5. Heart
integer
C0031809 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
physical examination of heart
Code List
5. Heart
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
heart abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Item
6. Lungs
integer
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
physical examination of heart
Code List
6. Lungs
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
lung abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
Item
7. Breasts
integer
C0031809 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
physical examination of heart
Code List
7. Breasts
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
breasts abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
Item
8. Abdomen
integer
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
physical examination of heart
Code List
8. Abdomen
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
abdomen abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Item
9. External Genitalia
integer
C0031809 (UMLS CUI [1,1])
C0227605 (UMLS CUI [1,2])
physical examination of heart
Code List
9. External Genitalia
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
external genitalia abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0227605 (UMLS CUI [1,2])
Item
10. Pelvic
integer
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
physical examination of heart
Code List
10. Pelvic
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
pelvis abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Item
11. Rectal
integer
C0199900 (UMLS CUI [1])
physical examination of heart
Code List
11. Rectal
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
rectum abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
Item
12. Extremities/Joints
integer
C0031809 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
physical examination of heart
Code List
12. Extremities/Joints
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
extremities/joints abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
Item
13. Neurological
integer
C0027853 (UMLS CUI [1])
physical examination of heart
Code List
13. Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
neurological examination abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
Item
14. Mental Status
integer
C0278060 (UMLS CUI [1])
physical examination of heart
Code List
14. Mental Status
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
mental status examination abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Item Group
Laboratory Evaluations (Central Lab)
C0022877 (UMLS CUI-1)
ChemistryLabCollectedDate
Item
Chemistry Sample Date
date
C0007996 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematology Sample Date
Item
Hematology Sample Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Serum beta-hcg
Item
Serum Beta-hCG Sample Date
date
C0229671 (UMLS CUI [1,1])
C0106132 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Serum beta-hCG
integer
C0229671 (UMLS CUI [1,1])
C0106132 (UMLS CUI [1,2])
Serum beta-hCG finding
Code List
Serum beta-hCG
CL Item
NA (1)
CL Item
Negative (2)
CL Item
Positive (3)
Item Group
Concomitant Medication
Concomitant Medication
Item
Are there any prior medication taken within the last 30 days?
boolean
C2347852 (UMLS CUI [1])
Item Group
Washout/Drug Dispensing
Washout/Drug Dispensing
Item
Is the patient currently taking phosphate binder(s)?
boolean
C1710661 (UMLS CUI [1,1])
C2267031 (UMLS CUI [1,2])
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