ID
17469
Beskrivning
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
Länk
https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A
Nyckelord
Versioner (3)
- 2016-09-13 2016-09-13 -
- 2016-09-13 2016-09-13 -
- 2016-09-16 2016-09-16 -
Uppladdad den
16 september 2016
DOI
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Licens
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
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
age
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
concomitant use of phosphate binders
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0357221
Beskrivning
fasting or dieting
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C2945766
Beskrivning
Serum phosphorus measurement
Datatyp
integer
Alias
- UMLS CUI [1]
- C0202178
Beskrivning
hydroxyvitamin D and iPTH
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0535968
- UMLS CUI [2]
- C0202159
Beskrivning
compliant to sevelamer carbonate
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1721288
Beskrivning
stable doses
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0042866
- UMLS CUI [1,3]
- C1337242
Beskrivning
contact to aluminium, magnesium, calcium or lanthanum
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002367
- UMLS CUI [2]
- C0006675
- UMLS CUI [3]
- C0024467
- UMLS CUI [4]
- C0023031
Beskrivning
contraception
Datatyp
integer
Alias
- UMLS CUI [1]
- C0700589
Beskrivning
dialysis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011946
Beskrivning
compliant to phosphate binders
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C4020599
Beskrivning
informed consent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
study participation status
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beskrivning
study compliance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1321605
Beskrivning
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021843
- UMLS CUI [2]
- C0011168
- UMLS CUI [3]
- C0011168
- UMLS CUI [4,1]
- C0854121
- UMLS CUI [4,2]
- C0205082
Beskrivning
active substance abuse
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beskrivning
use of anti-arrhythmic or anti-seizure drugs
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0003195
- UMLS CUI [1,2]
- C0003286
Beskrivning
unstable comorbidity
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beskrivning
pregnant or breast-feeding
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beskrivning
malignant neoplasms
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0006826
Beskrivning
study protocol compliance
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C1321605
Beskrivning
hypersensitivity to study drug
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C071805
Beskrivning
comorbidity prohibiting study inclusion
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beskrivning
date informed consent signed
Datatyp
date
Alias
- UMLS CUI [1]
- C2985782
Beskrivning
Patient met all enrollment criteria?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1302261
Beskrivning
Patient demographics
Alias
- UMLS CUI-1
- C1955348
Beskrivning
date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Ethnicity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
if previous answered with other, please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
sex
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Smoker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0543414
Beskrivning
Diabetes mellitus
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011849
Beskrivning
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Heart Rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Respiratory Rate
Datatyp
integer
Måttenheter
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beskrivning
Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Weight and Height
Alias
- UMLS CUI-1
- C0005910
- UMLS CUI-3
- C0005890
Beskrivning
Medical/Surgical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Beskrivning
Body System
Datatyp
text
Alias
- UMLS CUI [1]
- C0460002
Beskrivning
medical history
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262926
Beskrivning
if yes (@medical history), speficy in appropriate description field
Datatyp
text
Alias
- UMLS CUI [1]
- C3827351
Beskrivning
if yes (@medical history), speficy in appropriate description field:
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C3645583
Beskrivning
Renal history
Alias
- UMLS CUI-1
- C2136530
Beskrivning
Primary cause of ESRD
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Beskrivning
if previous item answered with other, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2316810
- UMLS CUI [1,2]
- C0015127
Beskrivning
kidney transplant
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0022671
Beskrivning
currently on Vitamin D
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2936842
Beskrivning
parathyroidectomy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0079989
Beskrivning
serum creatinine measurement No. 1 of 3
Datatyp
integer
Måttenheter
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
serum creatinine measurement No. 2 of 3
Datatyp
integer
Måttenheter
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
serum creatinine measurement No. 3 of 3
Datatyp
integer
Måttenheter
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
2. Type of Current Phosphate Binders:
Alias
- UMLS CUI-1
- C4020599
Beskrivning
type of current phosphate binders applicable?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C4020599
- UMLS CUI [1,2]
- C1706839
Beskrivning
Calcium Carbonate
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0006681
Beskrivning
Calcium Carbonate (Total daily dose)
Datatyp
float
Måttenheter
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0006681
Beskrivning
Calcium Acetate
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0717537
Beskrivning
Calcium Acetate (Total daily dose)
Datatyp
float
Måttenheter
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0717537
Beskrivning
Aluminium
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002367
Beskrivning
Aluminium (Total daily dose)
Datatyp
float
Måttenheter
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0002367
Beskrivning
Renagel
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0526563
Beskrivning
RenaGel (Total daily dose)
Datatyp
float
Måttenheter
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0526563
Beskrivning
Lanthanum
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0768119
Beskrivning
Lanthanum (Total daily dose)
Datatyp
float
Måttenheter
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0768119
Beskrivning
other phosphate binder
Datatyp
text
Alias
- UMLS CUI [1]
- C2267031
Beskrivning
Other phosphate binder (Total daily dose)
Datatyp
float
Måttenheter
- mg/day
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C2267031
Beskrivning
Physical Exam
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Date of physical exam
Datatyp
date
Alias
- UMLS CUI [1]
- C2826643
Beskrivning
General Appearance
Datatyp
integer
Alias
- UMLS CUI [1]
- C1148438
Beskrivning
General appearance abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C1704258
Beskrivning
physical examination of skin
Datatyp
integer
Alias
- UMLS CUI [1]
- C0436149
Beskrivning
skin abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0436149
Beskrivning
physical examination of HEENT
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Beskrivning
HEENT abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1512338
Beskrivning
physical examination of lymph nodes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Beskrivning
Lymph nodes abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024204
Beskrivning
physical examination of heart
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
Beskrivning
heart abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0018787
Beskrivning
physical examination of lungs
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
Beskrivning
lung abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0024109
Beskrivning
physical examination of breast
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0006141
Beskrivning
breasts abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0006141
Beskrivning
physical examination of abdomen
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beskrivning
abdomen abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0000726
Beskrivning
physical examination of external genitalia
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0227605
Beskrivning
external genitalia abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0227605
Beskrivning
physical examination of pelvis
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0030797
Beskrivning
pelvis abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0030797
Beskrivning
rectal examination
Datatyp
integer
Alias
- UMLS CUI [1]
- C0199900
Beskrivning
rectum abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0199900
Beskrivning
physical examination of Extremities/Joints
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [2,1]
- C0031809
- UMLS CUI [2,2]
- C0022417
Beskrivning
extremities/joints abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0022417
Beskrivning
neurological examination
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027853
Beskrivning
neurological examination abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027853
Beskrivning
mental status examination
Datatyp
integer
Alias
- UMLS CUI [1]
- C0278060
Beskrivning
mental status examination abnormal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beskrivning
Laboratory Evaluations (Central Lab)
Alias
- UMLS CUI-1
- C0022877
Beskrivning
ChemistryLabCollectedDate
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Beskrivning
Hematology Sample Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Beskrivning
Serum beta-hcg
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0106132
- UMLS CUI [1,3]
- C0011008
Beskrivning
Serum beta-hCG finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0106132
Beskrivning
Concomitant Medication
Beskrivning
Washout/Drug Dispensing
Beskrivning
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).
Datatyp
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])