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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
Ähnliche Modelle
Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient ID Number
Item
Patient ID Number
integer
C2348585 (UMLS CUI [1])
age
Item
1. Is the Patient a man or woman 18 years of age or older?
boolean
C0001779 (UMLS CUI [1])
Item
2. If the patient is currently taking phosphate binder(s) are they willing to stop this and enter a 2 week washout period?
integer
C2347852 (UMLS CUI [1,1])
C0357221 (UMLS CUI [1,2])
C0357221 (UMLS CUI [1,2])
Code List
2. If the patient is currently taking phosphate binder(s) are they willing to stop this and enter a 2 week washout period?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
fasting or dieting
Item
3. Is the patient willing to avoid any intentional changes in diet such as fasting or dieting?
boolean
C0015663 (UMLS CUI [1])
C2945766 (UMLS CUI [2])
C2945766 (UMLS CUI [2])
Item
4. If the patient is currently not taking a phosphate binder, does the patient have a Serum phosphorus measurement of >=5.5mg/dL (1.76 mmol/L) at Screening? (If taking a phosphate binder(s) at Screening, please tick NA)
integer
C0202178 (UMLS CUI [1])
Code List
4. If the patient is currently not taking a phosphate binder, does the patient have a Serum phosphorus measurement of >=5.5mg/dL (1.76 mmol/L) at Screening? (If taking a phosphate binder(s) at Screening, please tick NA)
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
hydroxyvitamin D and iPTH
Item
5. Does the patient have the following central laboratory measurements: a) 25-hydroxyvitamin-D >=10 ng/mL b) iPTH <=800 pg/mL
boolean
C0535968 (UMLS CUI [1])
C0202159 (UMLS CUI [2])
C0202159 (UMLS CUI [2])
compliant to sevelamer carbonate
Item
6. Is the patient willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study?
boolean
C1321605 (UMLS CUI [1,1])
C1721288 (UMLS CUI [1,2])
C1721288 (UMLS CUI [1,2])
stable doses
Item
7. Is the patient willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons?
boolean
C0678766 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
C1337242 (UMLS CUI [1,3])
C0042866 (UMLS CUI [1,2])
C1337242 (UMLS CUI [1,3])
contact to aluminium, magnesium, calcium or lanthanum
Item
8. Is the patient willing and able to avoid antacids and phosphate binders containing aluminium, magnesium, calcium or lanthanum for the duration of the study, except for safety reasons?
boolean
C0002367 (UMLS CUI [1])
C0006675 (UMLS CUI [2])
C0024467 (UMLS CUI [3])
C0023031 (UMLS CUI [4])
C0006675 (UMLS CUI [2])
C0024467 (UMLS CUI [3])
C0023031 (UMLS CUI [4])
Item
9. If female and of childbearing potential (pre-menopausal and not surgically steril), is the patient willing to use an effective contraceptive method throughout study, which includes barrier methods, Hormones, or IUDs?
integer
C0700589 (UMLS CUI [1])
Code List
9. If female and of childbearing potential (pre-menopausal and not surgically steril), is the patient willing to use an effective contraceptive method throughout study, which includes barrier methods, Hormones, or IUDs?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
dialysis
Item
10. Is the patient expected not to initiate dialysis for the duration of this study?
boolean
C0011946 (UMLS CUI [1])
compliant to phosphate binders
Item
11. Is the patient considered compliant with phosphate binders (if applicable)?
boolean
C1321605 (UMLS CUI [1,1])
C4020599 (UMLS CUI [1,2])
C4020599 (UMLS CUI [1,2])
informed consent
Item
12. Is the patient willing and able to provide informed consent?
boolean
C0021430 (UMLS CUI [1])
study participation status
Item
13. Has the patient not participated in any other investigational drug studies within 30 days prior to enrollment?
boolean
C2348568 (UMLS CUI [1])
study compliance
Item
14. Does the patient have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel?
boolean
C1321605 (UMLS CUI [1])
bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders
Item
1. Does the patient have active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders?
boolean
C0021843 (UMLS CUI [1])
C0011168 (UMLS CUI [2])
C0011168 (UMLS CUI [3])
C0854121 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0011168 (UMLS CUI [2])
C0011168 (UMLS CUI [3])
C0854121 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
active substance abuse
Item
2. Does the patient have an active Ethanol or drug abuse, excluding tobacco use?
boolean
C0038586 (UMLS CUI [1])
use of anti-arrhythmic or anti-seizure drugs
Item
3. Does the patient use anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders?
boolean
C0003195 (UMLS CUI [1,1])
C0003286 (UMLS CUI [1,2])
C0003286 (UMLS CUI [1,2])
unstable comorbidity
Item
4. In the opinion of the investigator, does the patient have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition?
boolean
C0009488 (UMLS CUI [1])
pregnant or breast-feeding
Item
5. If female, is the patient pregnant or breast feeding?
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
malignant neoplasms
Item
6. Does the patient have any evidence of active malignancy except for basal cell carcinoma of the skin?
boolean
C0006826 (UMLS CUI [1])
study protocol compliance
Item
7. Is the patient unable to comply with the requirements of the study?
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
hypersensitivity to study drug
Item
8. Does the patient have a known hypersensitivity to sevelamer or any constituents of the study drug?
boolean
C0020517 (UMLS CUI [1,1])
C071805 (UMLS CUI [1,2])
C071805 (UMLS CUI [1,2])
comorbidity prohibiting study inclusion
Item
9. Does the patient have any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study?
boolean
C0009488 (UMLS CUI [1])
date informed consent signed
Item
Date Informed Consent signed
date
C2985782 (UMLS CUI [1])
Patient met all enrollment criteria?
Item
Patient met all enrollment criteria?
boolean
C1302261 (UMLS CUI [1])
date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Caucasian (1)
CL Item
Black (2)
CL Item
Hispanic (3)
CL Item
Asian (4)
CL Item
Other (5)
if previous answered with other, please specify
Item
if previous answered with other, please specify:
text
C0015031 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
Smoker
Item
Smoker?
boolean
C0543414 (UMLS CUI [1])
Diabetes mellitus
Item
Diabetes mellitus?
boolean
C0011849 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Respiratory Rate
Item
Respiratory Rate
integer
C0231832 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item Group
Medical/Surgical History
C0262926 (UMLS CUI-1)
C0455610 (UMLS CUI-2)
C0455610 (UMLS CUI-2)
Body System
Item
Body System
text
C0460002 (UMLS CUI [1])
medical history
Item
History?
boolean
C0262926 (UMLS CUI [1])
if yes (@medical history), speficy in appropriate description field
Item
Current:
text
C3827351 (UMLS CUI [1])
if yes (@medical history), speficy in appropriate description field:
Item
Non-current:
text
C0012634 (UMLS CUI [1,1])
C3645583 (UMLS CUI [1,2])
C3645583 (UMLS CUI [1,2])
Item
1. Primary cause of ESRD
integer
C2316810 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
CL Item
Hypertension (1)
CL Item
Glomerulonephritis (2)
CL Item
Diabetes (3)
CL Item
Pyelonephritis (4)
CL Item
Polycystic Kidneys (5)
CL Item
Hydronephrosis (6)
CL Item
Interstitial Nephritis (7)
CL Item
Vasculitis (8)
CL Item
Congenital (9)
CL Item
Other, specify (next item) (10)
if previous item answered with other, please specify
Item
if previous item answered with other, please specify
text
C2316810 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
kidney transplant
Item
3. Has the patient ever had a kidney transplant?
boolean
C0022671 (UMLS CUI [1])
currently on Vitamin D
Item
4. Is the patient currently on Vitamin D?
boolean
C2936842 (UMLS CUI [1])
parathyroidectomy
Item
5. Has the aptient had a parathyroidectomy?
boolean
C0079989 (UMLS CUI [1])
serum creatinine measurement No. 1 of 3
Item
6. Patients last three Serum Creatinine measurements: No.1 of 3
integer
C0201976 (UMLS CUI [1])
serum creatinine measurement No. 2 of 3
Item
6. Patients last three Serum Creatinine measurements: No.2 of 3
integer
C0201976 (UMLS CUI [1])
serum creatinine measurement No. 3 of 3
Item
6. Patients last three Serum Creatinine measurements: No.3 of 3
integer
C0201976 (UMLS CUI [1])
Item Group
2. Type of Current Phosphate Binders:
C4020599 (UMLS CUI-1)
type of current phosphate binders applicable?
Item
type of current phosphate binders applicable?
boolean
C4020599 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,2])
Calcium Carbonate
Item
Calcium Carbonate
boolean
C0006681 (UMLS CUI [1])
Calcium Carbonate (Total daily dose)
Item
Calcium Carbonate (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0006681 (UMLS CUI [1,2])
C0006681 (UMLS CUI [1,2])
Calcium Acetate
Item
Calcium Acetate
boolean
C0717537 (UMLS CUI [1])
Calcium Acetate (Total daily dose)
Item
Calcium Acetate (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0717537 (UMLS CUI [1,2])
C0717537 (UMLS CUI [1,2])
Aluminium
Item
Aluminium
boolean
C0002367 (UMLS CUI [1])
Aluminium (Total daily dose)
Item
Aluminium (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0002367 (UMLS CUI [1,2])
C0002367 (UMLS CUI [1,2])
Renagel
Item
Renagel
boolean
C0526563 (UMLS CUI [1])
RenaGel (Total daily dose)
Item
RenaGel (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0526563 (UMLS CUI [1,2])
C0526563 (UMLS CUI [1,2])
Lanthanum
Item
Lanthanum
boolean
C0768119 (UMLS CUI [1])
Lanthanum (Total daily dose)
Item
Lanthanum (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C0768119 (UMLS CUI [1,2])
C0768119 (UMLS CUI [1,2])
other phosphate binder
Item
Other, specify:
text
C2267031 (UMLS CUI [1])
Other phosphate binder (Total daily dose)
Item
Other phosphate binder (Total daily dose)
float
C2348070 (UMLS CUI [1,1])
C2267031 (UMLS CUI [1,2])
C2267031 (UMLS CUI [1,2])
Date of physical exam
Item
Date:
date
C2826643 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
General appearance abnormal
Item
if abnormal, explain:
text
C1148438 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
skin abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0436149 (UMLS CUI [1,2])
C0436149 (UMLS CUI [1,2])
Item
3. HEENT
integer
C0031809 (UMLS CUI [1,1])
C1512338 (UMLS CUI [1,2])
C1512338 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
HEENT abnormal
Item
if abnormal, explain:
text
C0031809 (UMLS CUI [1,1])
C1512338 (UMLS CUI [1,2])
C1512338 (UMLS CUI [1,2])
Item
4. Lymph Nodes
integer
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Examined (3)
Lymph nodes abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
Item
5. Heart
integer
C0031809 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0018787 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
heart abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0018787 (UMLS CUI [1,2])
Item
6. Lungs
integer
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
lung abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,2])
Item
7. Breasts
integer
C0031809 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
breasts abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,2])
Item
8. Abdomen
integer
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
abdomen abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
Item
9. External Genitalia
integer
C0031809 (UMLS CUI [1,1])
C0227605 (UMLS CUI [1,2])
C0227605 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
external genitalia abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0227605 (UMLS CUI [1,2])
C0227605 (UMLS CUI [1,2])
Item
10. Pelvic
integer
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0030797 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
pelvis abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0030797 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
rectum abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
C0199900 (UMLS CUI [1,2])
Item
12. Extremities/Joints
integer
C0031809 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
C0015385 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
extremities/joints abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
C0015385 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0022417 (UMLS CUI [2,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
neurological examination abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C0027853 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
mental status examination abnormal
Item
if abnormal, explain:
text
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
C0278060 (UMLS CUI [1,2])
ChemistryLabCollectedDate
Item
Chemistry Sample Date
date
C0007996 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematology Sample Date
Item
Hematology Sample Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Serum beta-hcg
Item
Serum Beta-hCG Sample Date
date
C0229671 (UMLS CUI [1,1])
C0106132 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0106132 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Serum beta-hCG
integer
C0229671 (UMLS CUI [1,1])
C0106132 (UMLS CUI [1,2])
C0106132 (UMLS CUI [1,2])
CL Item
NA (1)
CL Item
Negative (2)
CL Item
Positive (3)
Concomitant Medication
Item
Are there any prior medication taken within the last 30 days?
boolean
C2347852 (UMLS CUI [1])
Washout/Drug Dispensing
Item
Is the patient currently taking phosphate binder(s)?
boolean
C1710661 (UMLS CUI [1,1])
C2267031 (UMLS CUI [1,2])
C2267031 (UMLS CUI [1,2])