ID
17469
Beschreibung
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
Stichworte
Versionen (3)
- 13.09.16 13.09.16 -
- 13.09.16 13.09.16 -
- 16.09.16 16.09.16 -
Hochgeladen am
16. September 2016
DOI
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Lizenz
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
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
concomitant use of phosphate binders
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0357221
Beschreibung
fasting or dieting
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C2945766
Beschreibung
Serum phosphorus measurement
Datentyp
integer
Alias
- UMLS CUI [1]
- C0202178
Beschreibung
hydroxyvitamin D and iPTH
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0535968
- UMLS CUI [2]
- C0202159
Beschreibung
compliant to sevelamer carbonate
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1721288
Beschreibung
stable doses
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0042866
- UMLS CUI [1,3]
- C1337242
Beschreibung
contact to aluminium, magnesium, calcium or lanthanum
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0002367
- UMLS CUI [2]
- C0006675
- UMLS CUI [3]
- C0024467
- UMLS CUI [4]
- C0023031
Beschreibung
contraception
Datentyp
integer
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
dialysis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011946
Beschreibung
compliant to phosphate binders
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C4020599
Beschreibung
informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
study participation status
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
study compliance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschreibung
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021843
- UMLS CUI [2]
- C0011168
- UMLS CUI [3]
- C0011168
- UMLS CUI [4,1]
- C0854121
- UMLS CUI [4,2]
- C0205082
Beschreibung
active substance abuse
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschreibung
use of anti-arrhythmic or anti-seizure drugs
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0003195
- UMLS CUI [1,2]
- C0003286
Beschreibung
unstable comorbidity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
pregnant or breast-feeding
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschreibung
malignant neoplasms
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschreibung
study protocol compliance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C1321605
Beschreibung
hypersensitivity to study drug
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C071805
Beschreibung
comorbidity prohibiting study inclusion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
date informed consent signed
Datentyp
date
Alias
- UMLS CUI [1]
- C2985782
Beschreibung
Patient met all enrollment criteria?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1302261
Beschreibung
Patient demographics
Alias
- UMLS CUI-1
- C1955348
Beschreibung
date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Ethnicity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
if previous answered with other, please specify
Datentyp
text
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
sex
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Smoker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0543414
Beschreibung
Diabetes mellitus
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011849
Beschreibung
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Respiratory Rate
Datentyp
integer
Maßeinheiten
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Weight and Height
Alias
- UMLS CUI-1
- C0005910
- UMLS CUI-3
- C0005890
Beschreibung
Medical/Surgical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Beschreibung
Body System
Datentyp
text
Alias
- UMLS CUI [1]
- C0460002
Beschreibung
medical history
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262926
Beschreibung
if yes (@medical history), speficy in appropriate description field
Datentyp
text
Alias
- UMLS CUI [1]
- C3827351
Beschreibung
if yes (@medical history), speficy in appropriate description field:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C3645583
Beschreibung
Renal history
Alias
- UMLS CUI-1
- C2136530
Beschreibung
Primary cause of ESRD
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Beschreibung
if previous item answered with other, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Beschreibung
kidney transplant
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0022671
Beschreibung
currently on Vitamin D
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2936842
Beschreibung
parathyroidectomy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0079989
Beschreibung
serum creatinine measurement No. 1 of 3
Datentyp
integer
Maßeinheiten
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
serum creatinine measurement No. 2 of 3
Datentyp
integer
Maßeinheiten
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
serum creatinine measurement No. 3 of 3
Datentyp
integer
Maßeinheiten
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
2. Type of Current Phosphate Binders:
Alias
- UMLS CUI-1
- C4020599
Beschreibung
type of current phosphate binders applicable?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C4020599
- UMLS CUI [1,2]
- C1706839
Beschreibung
Calcium Carbonate
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0006681
Beschreibung
Calcium Carbonate (Total daily dose)
Datentyp
float
Maßeinheiten
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0006681
Beschreibung
Calcium Acetate
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0717537
Beschreibung
Calcium Acetate (Total daily dose)
Datentyp
float
Maßeinheiten
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0717537
Beschreibung
Aluminium
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0002367
Beschreibung
Aluminium (Total daily dose)
Datentyp
float
Maßeinheiten
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0002367
Beschreibung
Renagel
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0526563
Beschreibung
RenaGel (Total daily dose)
Datentyp
float
Maßeinheiten
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0526563
Beschreibung
Lanthanum
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0768119
Beschreibung
Lanthanum (Total daily dose)
Datentyp
float
Maßeinheiten
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0768119
Beschreibung
other phosphate binder
Datentyp
text
Alias
- UMLS CUI [1]
- C2267031
Beschreibung
Other phosphate binder (Total daily dose)
Datentyp
float
Maßeinheiten
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C2267031
Beschreibung
Physical Exam
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Date of physical exam
Datentyp
date
Alias
- UMLS CUI [1]
- C2826643
Beschreibung
General Appearance
Datentyp
integer
Alias
- UMLS CUI [1]
- C1148438
Beschreibung
General appearance abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C1704258
Beschreibung
physical examination of skin
Datentyp
integer
Alias
- UMLS CUI [1]
- C0436149
Beschreibung
skin abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0436149
Beschreibung
physical examination of HEENT
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Beschreibung
HEENT abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Beschreibung
physical examination of lymph nodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Beschreibung
Lymph nodes abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024204
Beschreibung
physical examination of heart
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
Beschreibung
heart abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0018787
Beschreibung
physical examination of lungs
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
Beschreibung
lung abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024109
Beschreibung
physical examination of breast
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0006141
Beschreibung
breasts abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0006141
Beschreibung
physical examination of abdomen
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beschreibung
abdomen abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0000726
Beschreibung
physical examination of external genitalia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0227605
Beschreibung
external genitalia abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0227605
Beschreibung
physical examination of pelvis
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
Beschreibung
pelvis abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0030797
Beschreibung
rectal examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0199900
Beschreibung
rectum abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0199900
Beschreibung
physical examination of Extremities/Joints
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [2,1]
- C0031809
- UMLS CUI [2,2]
- C0022417
Beschreibung
extremities/joints abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0022417
Beschreibung
neurological examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
neurological examination abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027853
Beschreibung
mental status examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0278060
Beschreibung
mental status examination abnormal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beschreibung
Laboratory Evaluations (Central Lab)
Alias
- UMLS CUI-1
- C0022877
Beschreibung
ChemistryLabCollectedDate
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Beschreibung
Hematology Sample Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Beschreibung
Serum beta-hcg
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0106132
- UMLS CUI [1,3]
- C0011008
Beschreibung
Serum beta-hCG finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0106132
Beschreibung
Concomitant Medication
Beschreibung
Washout/Drug Dispensing
Beschreibung
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).
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710661
- UMLS CUI [1,2]
- C2267031
Ähnliche Modelle
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])