The Slo-Niacin trial. A trial of phosphate lowering agent slo-Niacin in patients on haemodialysis.
Phase 3
Completed
- Conditions
- End stage renal failure.Chronic Kidney disease - mineral bone disorder.Hyperphosphataemia.Renal and Urogenital - Kidney diseaseMetabolic and Endocrine - Other metabolic disorders
- Registration Number
- ACTRN12611000500954
- Lead Sponsor
- Dr. Ken-Soon Tan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
1. Adult patients with end stage renal failure on maintenance haemodialysis.
2. Patients with hyperphosphataemia in context of the above.
Exclusion Criteria
1. Patients unable to give informed consent.
2. Pregnant patients.
3. Patients enrolled in other trials of medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum phosphate, measured weekly[24 weeks (duration of trial)]
- Secondary Outcome Measures
Name Time Method Safety and tolerability of active treatment compared to placebo.<br><br>1. Presence of side effects attributable to niacin: flushing, intradialytic hypotension, gastrointestinal upset. Monitored weekly by patient assessment.<br><br>2. Presence of hepato-toxicity: liver funciton tests monitored weekly.[24 weeks (duration of trial)]