NCT01200784CompletedPhase 2
Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Medice Arzneimittel Pütter GmbH & Co KG0 sites252 target enrollmentStarted: August 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 252
- Primary Endpoint
- serum phosphate
Study Overview
Brief Summary
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
250 mg/d modified release Nicotinamide
Experimental
Intervention: Nicotinamide (Drug)
500 mg/d modified release Nicotinamide
Experimental
Intervention: Nicotinamide (Drug)
750 mg/d modified release Nicotinamide
Experimental
Intervention: Nicotinamide (Drug)
1000 mg/d modified release Nicotinamide
Experimental
Intervention: Nicotinamide (Drug)
1000 mg/d immidiate release Nicotinamide
Active Comparator
Intervention: Nicotinamide (Drug)
Outcomes
Primary Outcomes
serum phosphate
Time Frame: 4 weeks of active treatment
Secondary Outcomes
- 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)
Investigators
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