ID
17469
Beschrijving
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
Trefwoorden
Versies (3)
- 13-09-16 13-09-16 -
- 13-09-16 13-09-16 -
- 16-09-16 16-09-16 -
Geüploaded op
16 september 2016
DOI
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Licentie
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
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
concomitant use of phosphate binders
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0357221
Beschrijving
fasting or dieting
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C2945766
Beschrijving
Serum phosphorus measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C0202178
Beschrijving
hydroxyvitamin D and iPTH
Datatype
boolean
Alias
- UMLS CUI [1]
- C0535968
- UMLS CUI [2]
- C0202159
Beschrijving
compliant to sevelamer carbonate
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1721288
Beschrijving
stable doses
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0042866
- UMLS CUI [1,3]
- C1337242
Beschrijving
contact to aluminium, magnesium, calcium or lanthanum
Datatype
boolean
Alias
- UMLS CUI [1]
- C0002367
- UMLS CUI [2]
- C0006675
- UMLS CUI [3]
- C0024467
- UMLS CUI [4]
- C0023031
Beschrijving
contraception
Datatype
integer
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
dialysis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011946
Beschrijving
compliant to phosphate binders
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C4020599
Beschrijving
informed consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
study participation status
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
study compliance
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021843
- UMLS CUI [2]
- C0011168
- UMLS CUI [3]
- C0011168
- UMLS CUI [4,1]
- C0854121
- UMLS CUI [4,2]
- C0205082
Beschrijving
active substance abuse
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschrijving
use of anti-arrhythmic or anti-seizure drugs
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0003195
- UMLS CUI [1,2]
- C0003286
Beschrijving
unstable comorbidity
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
pregnant or breast-feeding
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschrijving
malignant neoplasms
Datatype
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschrijving
study protocol compliance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C1321605
Beschrijving
hypersensitivity to study drug
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C071805
Beschrijving
comorbidity prohibiting study inclusion
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
date informed consent signed
Datatype
date
Alias
- UMLS CUI [1]
- C2985782
Beschrijving
Patient met all enrollment criteria?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1302261
Beschrijving
Patient demographics
Alias
- UMLS CUI-1
- C1955348
Beschrijving
date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Ethnicity
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
if previous answered with other, please specify
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
sex
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Smoker
Datatype
boolean
Alias
- UMLS CUI [1]
- C0543414
Beschrijving
Diabetes mellitus
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011849
Beschrijving
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Respiratory Rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Weight and Height
Alias
- UMLS CUI-1
- C0005910
- UMLS CUI-3
- C0005890
Beschrijving
Medical/Surgical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Beschrijving
Body System
Datatype
text
Alias
- UMLS CUI [1]
- C0460002
Beschrijving
medical history
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262926
Beschrijving
if yes (@medical history), speficy in appropriate description field
Datatype
text
Alias
- UMLS CUI [1]
- C3827351
Beschrijving
if yes (@medical history), speficy in appropriate description field:
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C3645583
Beschrijving
Renal history
Alias
- UMLS CUI-1
- C2136530
Beschrijving
Primary cause of ESRD
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Beschrijving
if previous item answered with other, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Beschrijving
kidney transplant
Datatype
boolean
Alias
- UMLS CUI [1]
- C0022671
Beschrijving
currently on Vitamin D
Datatype
boolean
Alias
- UMLS CUI [1]
- C2936842
Beschrijving
parathyroidectomy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0079989
Beschrijving
serum creatinine measurement No. 1 of 3
Datatype
integer
Maateenheden
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
serum creatinine measurement No. 2 of 3
Datatype
integer
Maateenheden
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
serum creatinine measurement No. 3 of 3
Datatype
integer
Maateenheden
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
2. Type of Current Phosphate Binders:
Alias
- UMLS CUI-1
- C4020599
Beschrijving
type of current phosphate binders applicable?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C4020599
- UMLS CUI [1,2]
- C1706839
Beschrijving
Calcium Carbonate
Datatype
boolean
Alias
- UMLS CUI [1]
- C0006681
Beschrijving
Calcium Carbonate (Total daily dose)
Datatype
float
Maateenheden
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0006681
Beschrijving
Calcium Acetate
Datatype
boolean
Alias
- UMLS CUI [1]
- C0717537
Beschrijving
Calcium Acetate (Total daily dose)
Datatype
float
Maateenheden
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0717537
Beschrijving
Aluminium
Datatype
boolean
Alias
- UMLS CUI [1]
- C0002367
Beschrijving
Aluminium (Total daily dose)
Datatype
float
Maateenheden
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0002367
Beschrijving
Renagel
Datatype
boolean
Alias
- UMLS CUI [1]
- C0526563
Beschrijving
RenaGel (Total daily dose)
Datatype
float
Maateenheden
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0526563
Beschrijving
Lanthanum
Datatype
boolean
Alias
- UMLS CUI [1]
- C0768119
Beschrijving
Lanthanum (Total daily dose)
Datatype
float
Maateenheden
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0768119
Beschrijving
other phosphate binder
Datatype
text
Alias
- UMLS CUI [1]
- C2267031
Beschrijving
Other phosphate binder (Total daily dose)
Datatype
float
Maateenheden
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C2267031
Beschrijving
Physical Exam
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Date of physical exam
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
General Appearance
Datatype
integer
Alias
- UMLS CUI [1]
- C1148438
Beschrijving
General appearance abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C1704258
Beschrijving
physical examination of skin
Datatype
integer
Alias
- UMLS CUI [1]
- C0436149
Beschrijving
skin abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0436149
Beschrijving
physical examination of HEENT
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Beschrijving
HEENT abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Beschrijving
physical examination of lymph nodes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Beschrijving
Lymph nodes abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024204
Beschrijving
physical examination of heart
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
Beschrijving
heart abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0018787
Beschrijving
physical examination of lungs
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
Beschrijving
lung abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024109
Beschrijving
physical examination of breast
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0006141
Beschrijving
breasts abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0006141
Beschrijving
physical examination of abdomen
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beschrijving
abdomen abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0000726
Beschrijving
physical examination of external genitalia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0227605
Beschrijving
external genitalia abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0227605
Beschrijving
physical examination of pelvis
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
Beschrijving
pelvis abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0030797
Beschrijving
rectal examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0199900
Beschrijving
rectum abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0199900
Beschrijving
physical examination of Extremities/Joints
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [2,1]
- C0031809
- UMLS CUI [2,2]
- C0022417
Beschrijving
extremities/joints abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0022417
Beschrijving
neurological examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
neurological examination abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027853
Beschrijving
mental status examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0278060
Beschrijving
mental status examination abnormal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beschrijving
Laboratory Evaluations (Central Lab)
Alias
- UMLS CUI-1
- C0022877
Beschrijving
ChemistryLabCollectedDate
Datatype
date
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Beschrijving
Hematology Sample Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Beschrijving
Serum beta-hcg
Datatype
date
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0106132
- UMLS CUI [1,3]
- C0011008
Beschrijving
Serum beta-hCG finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0106132
Beschrijving
Concomitant Medication
Beschrijving
Washout/Drug Dispensing
Beschrijving
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).
Datatype
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])