ID
17469
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)
- 9/13/16 9/13/16 -
- 9/13/16 9/13/16 -
- 9/16/16 9/16/16 -
Uploaded on
September 16, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
- StudyEvent: ODM
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
concomitant use of phosphate binders
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0357221
Description
fasting or dieting
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C2945766
Description
Serum phosphorus measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0202178
Description
hydroxyvitamin D and iPTH
Data type
boolean
Alias
- UMLS CUI [1]
- C0535968
- UMLS CUI [2]
- C0202159
Description
compliant to sevelamer carbonate
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1721288
Description
stable doses
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0042866
- UMLS CUI [1,3]
- C1337242
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
Description
contraception
Data type
integer
Alias
- UMLS CUI [1]
- C0700589
Description
dialysis
Data type
boolean
Alias
- UMLS CUI [1]
- C0011946
Description
compliant to phosphate binders
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C4020599
Description
informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
study participation status
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
study compliance
Data type
boolean
Alias
- UMLS CUI [1]
- C1321605
Description
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
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
Description
active substance abuse
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
use of anti-arrhythmic or anti-seizure drugs
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0003195
- UMLS CUI [1,2]
- C0003286
Description
unstable comorbidity
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
pregnant or breast-feeding
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Description
malignant neoplasms
Data type
boolean
Alias
- UMLS CUI [1]
- C0006826
Description
study protocol compliance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C1321605
Description
hypersensitivity to study drug
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C071805
Description
comorbidity prohibiting study inclusion
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
date informed consent signed
Data type
date
Alias
- UMLS CUI [1]
- C2985782
Description
Patient met all enrollment criteria?
Data type
boolean
Alias
- UMLS CUI [1]
- C1302261
Description
Patient demographics
Alias
- UMLS CUI-1
- C1955348
Description
date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
if previous answered with other, please specify
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
sex
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Smoker
Data type
boolean
Alias
- UMLS CUI [1]
- C0543414
Description
Diabetes mellitus
Data type
boolean
Alias
- UMLS CUI [1]
- C0011849
Description
Vital signs
Alias
- UMLS CUI-1
- C0518766
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Respiratory Rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Weight and Height
Alias
- UMLS CUI-1
- C0005910
- UMLS CUI-3
- C0005890
Description
Medical/Surgical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Description
Body System
Data type
text
Alias
- UMLS CUI [1]
- C0460002
Description
medical history
Data type
boolean
Alias
- UMLS CUI [1]
- C0262926
Description
if yes (@medical history), speficy in appropriate description field
Data type
text
Alias
- UMLS CUI [1]
- C3827351
Description
if yes (@medical history), speficy in appropriate description field:
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C3645583
Description
Renal history
Alias
- UMLS CUI-1
- C2136530
Description
Primary cause of ESRD
Data type
integer
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Description
if previous item answered with other, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Description
kidney transplant
Data type
boolean
Alias
- UMLS CUI [1]
- C0022671
Description
currently on Vitamin D
Data type
boolean
Alias
- UMLS CUI [1]
- C2936842
Description
parathyroidectomy
Data type
boolean
Alias
- UMLS CUI [1]
- C0079989
Description
serum creatinine measurement No. 1 of 3
Data type
integer
Measurement units
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Description
serum creatinine measurement No. 2 of 3
Data type
integer
Measurement units
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Description
serum creatinine measurement No. 3 of 3
Data type
integer
Measurement units
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Description
2. Type of Current Phosphate Binders:
Alias
- UMLS CUI-1
- C4020599
Description
type of current phosphate binders applicable?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4020599
- UMLS CUI [1,2]
- C1706839
Description
Calcium Carbonate
Data type
boolean
Alias
- UMLS CUI [1]
- C0006681
Description
Calcium Carbonate (Total daily dose)
Data type
float
Measurement units
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0006681
Description
Calcium Acetate
Data type
boolean
Alias
- UMLS CUI [1]
- C0717537
Description
Calcium Acetate (Total daily dose)
Data type
float
Measurement units
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0717537
Description
Aluminium
Data type
boolean
Alias
- UMLS CUI [1]
- C0002367
Description
Aluminium (Total daily dose)
Data type
float
Measurement units
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0002367
Description
Renagel
Data type
boolean
Alias
- UMLS CUI [1]
- C0526563
Description
RenaGel (Total daily dose)
Data type
float
Measurement units
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0526563
Description
Lanthanum
Data type
boolean
Alias
- UMLS CUI [1]
- C0768119
Description
Lanthanum (Total daily dose)
Data type
float
Measurement units
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0768119
Description
other phosphate binder
Data type
text
Alias
- UMLS CUI [1]
- C2267031
Description
Other phosphate binder (Total daily dose)
Data type
float
Measurement units
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C2267031
Description
Physical Exam
Alias
- UMLS CUI-1
- C0031809
Description
Date of physical exam
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
General Appearance
Data type
integer
Alias
- UMLS CUI [1]
- C1148438
Description
General appearance abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C1704258
Description
physical examination of skin
Data type
integer
Alias
- UMLS CUI [1]
- C0436149
Description
skin abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0436149
Description
physical examination of HEENT
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Description
HEENT abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Description
physical examination of lymph nodes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Description
Lymph nodes abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024204
Description
physical examination of heart
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
Description
heart abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0018787
Description
physical examination of lungs
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
Description
lung abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024109
Description
physical examination of breast
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0006141
Description
breasts abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0006141
Description
physical examination of abdomen
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Description
abdomen abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0000726
Description
physical examination of external genitalia
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0227605
Description
external genitalia abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0227605
Description
physical examination of pelvis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
Description
pelvis abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0030797
Description
rectal examination
Data type
integer
Alias
- UMLS CUI [1]
- C0199900
Description
rectum abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0199900
Description
physical examination of Extremities/Joints
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [2,1]
- C0031809
- UMLS CUI [2,2]
- C0022417
Description
extremities/joints abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0022417
Description
neurological examination
Data type
integer
Alias
- UMLS CUI [1]
- C0027853
Description
neurological examination abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027853
Description
mental status examination
Data type
integer
Alias
- UMLS CUI [1]
- C0278060
Description
mental status examination abnormal
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Description
Laboratory Evaluations (Central Lab)
Alias
- UMLS CUI-1
- C0022877
Description
ChemistryLabCollectedDate
Data type
date
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Description
Hematology Sample Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Description
Serum beta-hcg
Data type
date
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0106132
- UMLS CUI [1,3]
- C0011008
Description
Serum beta-hCG finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0106132
Description
Concomitant Medication
Description
Washout/Drug Dispensing
Description
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).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710661
- UMLS CUI [1,2]
- C2267031
Similar models
Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
- StudyEvent: ODM
C0357221 (UMLS CUI [1,2])
C2945766 (UMLS CUI [2])
C0202159 (UMLS CUI [2])
C1721288 (UMLS CUI [1,2])
C0042866 (UMLS CUI [1,2])
C1337242 (UMLS CUI [1,3])
C0006675 (UMLS CUI [2])
C0024467 (UMLS CUI [3])
C0023031 (UMLS CUI [4])
C4020599 (UMLS CUI [1,2])
C0011168 (UMLS CUI [2])
C0011168 (UMLS CUI [3])
C0854121 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0003286 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
C071805 (UMLS CUI [1,2])
C0455610 (UMLS CUI-2)
C3645583 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,2])
C0006681 (UMLS CUI [1,2])
C0717537 (UMLS CUI [1,2])
C0002367 (UMLS CUI [1,2])
C0526563 (UMLS CUI [1,2])
C0768119 (UMLS CUI [1,2])
C2267031 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0436149 (UMLS CUI [1,2])
C1512338 (UMLS CUI [1,2])
C1512338 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
C0018787 (UMLS CUI [1,2])
C0018787 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
C0227605 (UMLS CUI [1,2])
C0227605 (UMLS CUI [1,2])
C0030797 (UMLS CUI [1,2])
C0030797 (UMLS CUI [1,2])
C0199900 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
C0015385 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
C0027853 (UMLS CUI [1,2])
C0278060 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0106132 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0106132 (UMLS CUI [1,2])
C2267031 (UMLS CUI [1,2])