ID

17423

Descrizione

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

collegamento

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

Keywords

versioni (3)
  1. 13/09/16 13/09/16 -
  2. 13/09/16 13/09/16 -
  3. 16/09/16 16/09/16 -
Caricato su

13 settembre 2016

DOI

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Licenza

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

Inglese

Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 moduli  
Patient administration
Descrizione

Patient administration

Patient Initials
Descrizione

Patient Initials

Tipo di dati

text

Alias
UMLS CUI [1]
C2986440
Patient ID Number
Descrizione

Patient ID Number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Descrizione

Inclusion Criteria

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

age

Tipo di dati

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?
Descrizione

concomitant use of phosphate binders

Tipo di dati

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?
Descrizione

fasting or dieting

Tipo di dati

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)
Descrizione

Serum phosphorus measurement

Tipo di dati

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
Descrizione

hydroxyvitamin D and iPTH

Tipo di dati

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?
Descrizione

compliant to sevelamer carbonate

Tipo di dati

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?
Descrizione

stable doses

Tipo di dati

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?
Descrizione

contact to aluminium, magnesium, calcium or lanthanum

Tipo di dati

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?
Descrizione

contraception

Tipo di dati

integer

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

dialysis

Tipo di dati

boolean

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

compliant to phosphate binders

Tipo di dati

boolean

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

informed consent

Tipo di dati

boolean

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

study participation status

Tipo di dati

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?
Descrizione

study compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion criteria
Descrizione

Exclusion criteria

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

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

Tipo di dati

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?
Descrizione

active substance abuse

Tipo di dati

boolean

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

use of anti-arrhythmic or anti-seizure drugs

Tipo di dati

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?
Descrizione

unstable comorbidity

Tipo di dati

boolean

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

pregnant or breast-feeding

Tipo di dati

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?
Descrizione

malignant neoplasms

Tipo di dati

boolean

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

study protocol compliance

Tipo di dati

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?
Descrizione

hypersensitivity to study drug

Tipo di dati

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?
Descrizione

comorbidity prohibiting study inclusion

Tipo di dati

boolean

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

date informed consent signed

Tipo di dati

date

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

Patient met all enrollment criteria?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1302261
Patient demographics
Descrizione

Patient demographics

Alias
UMLS CUI-1
C1955348
Date of birth
Descrizione

date of birth

Tipo di dati

date

Alias
UMLS CUI [1]
C0421451
Ethnicity:
Descrizione

Ethnicity

Tipo di dati

integer

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

if previous answered with other, please specify

Tipo di dati

text

Alias
UMLS CUI [1]
C0015031
Sex:
Descrizione

sex

Tipo di dati

integer

Alias
UMLS CUI [1]
C0079399
Smoker?
Descrizione

Smoker

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0543414
Diabetes mellitus?
Descrizione

Diabetes mellitus

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011849
Vital signs
Descrizione

Vital signs

Alias
UMLS CUI-1
C0518766
Heart Rate
Descrizione

Heart Rate

Tipo di dati

integer

Unità di misura
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiratory Rate
Descrizione

Respiratory Rate

Tipo di dati

integer

Unità di misura
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Systolic Blood Pressure
Descrizione

Systolic Blood Pressure

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descrizione

Diastolic Blood Pressure

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Weight and Height
Descrizione

Weight and Height

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

Weight

Tipo di dati

float

Unità di misura
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Descrizione

Height

Tipo di dati

float

Unità di misura
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Medical/Surgical History
Descrizione

Medical/Surgical History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0455610
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Similar models

Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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)
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