Status:
COMPLETED
Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Lead Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
Conditions:
Chronic Kidney Disease
Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01200784
Start Date
August 1 2010
End Date
July 1 2011
Last Update
January 18 2012
Active Locations (36)
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1
Alsfeld, Germany, 36304
2
Arnstadt, Germany, 99310
3
Augsburg, Germany, 86157
4
Berlin, Germany, 12045