ID

17423

Description

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

Keywords

Versions (3)
  1. 9/13/16 9/13/16 -
  2. 9/13/16 9/13/16 -
  3. 9/16/16 9/16/16 -
Uploaded on

September 13, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

English

Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 forms  
Patient administration
Description

Patient administration

Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient ID Number
Description

Patient ID Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Description

Inclusion Criteria

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

age

Data type

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?
Description

concomitant use of phosphate binders

Data type

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?
Description

fasting or dieting

Data type

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)
Description

Serum phosphorus measurement

Data type

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
Description

hydroxyvitamin D and iPTH

Data type

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?
Description

compliant to sevelamer carbonate

Data type

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?
Description

stable doses

Data type

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?
Description

contact to aluminium, magnesium, calcium or lanthanum

Data type

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?
Description

contraception

Data type

integer

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

dialysis

Data type

boolean

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

compliant to phosphate binders

Data type

boolean

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

informed consent

Data type

boolean

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

study participation status

Data type

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?
Description

study compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion criteria
Description

Exclusion criteria

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

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

Data type

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?
Description

active substance abuse

Data type

boolean

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

use of anti-arrhythmic or anti-seizure drugs

Data type

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?
Description

unstable comorbidity

Data type

boolean

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

pregnant or breast-feeding

Data type

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?
Description

malignant neoplasms

Data type

boolean

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

study protocol compliance

Data type

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?
Description

hypersensitivity to study drug

Data type

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?
Description

comorbidity prohibiting study inclusion

Data type

boolean

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

date informed consent signed

Data type

date

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

Patient met all enrollment criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1302261
Patient demographics
Description

Patient demographics

Alias
UMLS CUI-1
C1955348
Date of birth
Description

date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Ethnicity:
Description

Ethnicity

Data type

integer

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

if previous answered with other, please specify

Data type

text

Alias
UMLS CUI [1]
C0015031
Sex:
Description

sex

Data type

integer

Alias
UMLS CUI [1]
C0079399
Smoker?
Description

Smoker

Data type

boolean

Alias
UMLS CUI [1]
C0543414
Diabetes mellitus?
Description

Diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiratory Rate
Description

Respiratory Rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Weight and Height
Description

Weight and Height

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

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Medical/Surgical History
Description

Medical/Surgical History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0455610
Back to the top of the page

Similar models

Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial