The Slo-Niacin trial. A trial of phosphate lowering agent "slo-Niacin" in patients on haemodialysis.

The effect of slow release nicotinic acid on serum phosphate in patients with end stage renal failure on maintenance haemodialysis and with persistently high serum phosphate levels.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000500954

Enrollment

Registered

2011-05-13

Start date

2011-06-22

Completion date

2012-07-26

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim: To determine the efficacy and tolerability of low doses of slow release nicotinic acid as a phosphate binder in haemodialysis patients with persistently high serum phosphate levels. Phosphate accumulates in patients with renal failure. A high phosphate level has been associated with higher mortality. Patients with end stage renal failure on dialysis often need to take medications to reduce serum phosphate. Unfortunately, these medications have complex dosing regimes, often cause side effects and are expensive. This leads to poor compliance and poor correction of serum phosphate. Nicotinic acid has been shown to have phosphate lowering effects. We propose to investigate the efficacy, safety and tolerability of a low dose of a once daily novel sustained release preparation of nicotinic acid (Slo niacin) in patients with end stage renal failure on haemodialysis who have problems with high phosphate levels.

Interventions

Total trial duration is 24 weeks. 4 week run in period on usual phosphate lowering medications and haemodialysis prescription. No adjustments permitted to either. Phase 1: 8 weeks Slow release Nicotinic Acid (slo-niacin) 500mg 1 capsule daily or placebo 1 capsule daily in addition to usual baseline phosphate lowering therapy and haemodialysis prescription. Washout period = 2 weeks. Phase 2: 8 weeks. Slow release Nicotinic Acid (slo-niacin) 500mg 1 capsule daily or placebo 1 capsule daily in addi

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results