Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Phase 2
Completed
- Conditions
- Chronic Kidney DiseaseHemodialysisHyperphosphatemia
- Interventions
- Registration Number
- NCT01200784
- Lead Sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Brief Summary
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 250 mg/d modified release Nicotinamide Nicotinamide - 750 mg/d modified release Nicotinamide Nicotinamide - 500 mg/d modified release Nicotinamide Nicotinamide - 1000 mg/d immidiate release Nicotinamide Nicotinamide - 1000 mg/d modified release Nicotinamide Nicotinamide -
- Primary Outcome Measures
Name Time Method serum phosphate 4 weeks of active treatment
- Secondary Outcome Measures
Name Time Method serum phosphate 8 weeks of active treatment serum calcium 4 and 8 weeks of acitve treatment serum PTH 4 and 8 weeks of active treatment adverse events 12 weeks