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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01200784 |
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Date of registration:
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10/09/2010 |
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Primary sponsor: |
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Public title:
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Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
DONATO |
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Scientific title:
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Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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252 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01200784 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Walter Zidek, Prof. Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- hemodialysis since 3 months or longer
- hemodialysis frequency 3 times weekly
- stable phosphate binder dose since one month at screening
- serum phosphate level < 2,42 mmol/l at screening
- serum phosphate level > 1,52 mmol/l after wash out phase
- stable treatment with vitamin D analogues since one month at screening
Exclusion Criteria:
- congestive heart failure
- acute bleeding complications
- acute myocardial infarction
- peptic ulcers
- serious liver damage
- poorly controlled diabetes
- severe visual impairment
- uncontrolled high blood pressure
- thrombocyte count < 120/nl
- difficulties in swallowing or dysphagia
- diminished intestinal motility, megacolon, pseudo- or mechanical obstruction
- gastroparesis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease
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Hemodialysis
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Hyperphosphatemia
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Intervention(s)
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Drug: Nicotinamide
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Primary Outcome(s)
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serum phosphate
[Time Frame: 4 weeks of active treatment]
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Secondary Outcome(s)
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adverse events
[Time Frame: 12 weeks]
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serum calcium
[Time Frame: 4 and 8 weeks of acitve treatment]
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serum phosphate
[Time Frame: 8 weeks of active treatment]
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serum PTH
[Time Frame: 4 and 8 weeks of active treatment]
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Secondary ID(s)
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2009-015821-34
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6520-9961-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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