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
Lien
https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A
Mots-clés
Versions (3)
- 13/09/2016 13/09/2016 -
- 13/09/2016 13/09/2016 -
- 16/09/2016 16/09/2016 -
Téléchargé le
16 septembre 2016
DOI
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Licence
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
concomitant use of phosphate binders
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0357221
Description
fasting or dieting
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C2945766
Description
Serum phosphorus measurement
Type de données
integer
Alias
- UMLS CUI [1]
- C0202178
Description
hydroxyvitamin D and iPTH
Type de données
boolean
Alias
- UMLS CUI [1]
- C0535968
- UMLS CUI [2]
- C0202159
Description
compliant to sevelamer carbonate
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1721288
Description
stable doses
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0002367
- UMLS CUI [2]
- C0006675
- UMLS CUI [3]
- C0024467
- UMLS CUI [4]
- C0023031
Description
contraception
Type de données
integer
Alias
- UMLS CUI [1]
- C0700589
Description
dialysis
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011946
Description
compliant to phosphate binders
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C4020599
Description
informed consent
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
study participation status
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
study compliance
Type de données
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
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
use of anti-arrhythmic or anti-seizure drugs
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0003195
- UMLS CUI [1,2]
- C0003286
Description
unstable comorbidity
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
pregnant or breast-feeding
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Description
malignant neoplasms
Type de données
boolean
Alias
- UMLS CUI [1]
- C0006826
Description
study protocol compliance
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C1321605
Description
hypersensitivity to study drug
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C071805
Description
comorbidity prohibiting study inclusion
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
date informed consent signed
Type de données
date
Alias
- UMLS CUI [1]
- C2985782
Description
Patient met all enrollment criteria?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1302261
Description
Patient demographics
Alias
- UMLS CUI-1
- C1955348
Description
date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Ethnicity
Type de données
integer
Alias
- UMLS CUI [1]
- C0015031
Description
if previous answered with other, please specify
Type de données
text
Alias
- UMLS CUI [1]
- C0015031
Description
sex
Type de données
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Smoker
Type de données
boolean
Alias
- UMLS CUI [1]
- C0543414
Description
Diabetes mellitus
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011849
Description
Vital signs
Alias
- UMLS CUI-1
- C0518766
Description
Heart Rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Respiratory Rate
Type de données
integer
Unités de mesure
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- 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
Type de données
text
Alias
- UMLS CUI [1]
- C0460002
Description
medical history
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262926
Description
if yes (@medical history), speficy in appropriate description field
Type de données
text
Alias
- UMLS CUI [1]
- C3827351
Description
if yes (@medical history), speficy in appropriate description field:
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Description
if previous item answered with other, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Description
kidney transplant
Type de données
boolean
Alias
- UMLS CUI [1]
- C0022671
Description
currently on Vitamin D
Type de données
boolean
Alias
- UMLS CUI [1]
- C2936842
Description
parathyroidectomy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0079989
Description
serum creatinine measurement No. 1 of 3
Type de données
integer
Unités de mesure
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Description
serum creatinine measurement No. 2 of 3
Type de données
integer
Unités de mesure
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Description
serum creatinine measurement No. 3 of 3
Type de données
integer
Unités de mesure
- 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?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C4020599
- UMLS CUI [1,2]
- C1706839
Description
Calcium Carbonate
Type de données
boolean
Alias
- UMLS CUI [1]
- C0006681
Description
Calcium Carbonate (Total daily dose)
Type de données
float
Unités de mesure
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0006681
Description
Calcium Acetate
Type de données
boolean
Alias
- UMLS CUI [1]
- C0717537
Description
Calcium Acetate (Total daily dose)
Type de données
float
Unités de mesure
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0717537
Description
Aluminium
Type de données
boolean
Alias
- UMLS CUI [1]
- C0002367
Description
Aluminium (Total daily dose)
Type de données
float
Unités de mesure
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0002367
Description
Renagel
Type de données
boolean
Alias
- UMLS CUI [1]
- C0526563
Description
RenaGel (Total daily dose)
Type de données
float
Unités de mesure
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0526563
Description
Lanthanum
Type de données
boolean
Alias
- UMLS CUI [1]
- C0768119
Description
Lanthanum (Total daily dose)
Type de données
float
Unités de mesure
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0768119
Description
other phosphate binder
Type de données
text
Alias
- UMLS CUI [1]
- C2267031
Description
Other phosphate binder (Total daily dose)
Type de données
float
Unités de mesure
- 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
Type de données
date
Alias
- UMLS CUI [1]
- C2826643
Description
General Appearance
Type de données
integer
Alias
- UMLS CUI [1]
- C1148438
Description
General appearance abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C1704258
Description
physical examination of skin
Type de données
integer
Alias
- UMLS CUI [1]
- C0436149
Description
skin abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0436149
Description
physical examination of HEENT
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Description
HEENT abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Description
physical examination of lymph nodes
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Description
Lymph nodes abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024204
Description
physical examination of heart
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
Description
heart abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0018787
Description
physical examination of lungs
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
Description
lung abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024109
Description
physical examination of breast
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0006141
Description
breasts abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0006141
Description
physical examination of abdomen
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Description
abdomen abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0000726
Description
physical examination of external genitalia
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0227605
Description
external genitalia abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0227605
Description
physical examination of pelvis
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
Description
pelvis abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0030797
Description
rectal examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0199900
Description
rectum abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0199900
Description
physical examination of Extremities/Joints
Type de données
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
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C0027853
Description
neurological examination abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027853
Description
mental status examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0278060
Description
mental status examination abnormal
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Description
Laboratory Evaluations (Central Lab)
Alias
- UMLS CUI-1
- C0022877
Description
ChemistryLabCollectedDate
Type de données
date
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Description
Hematology Sample Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Description
Serum beta-hcg
Type de données
date
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0106132
- UMLS CUI [1,3]
- C0011008
Description
Serum beta-hCG finding
Type de données
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).
Type de données
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])