Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000500954
Ethics application status
Approved
Date submitted
11/05/2011
Date registered
13/05/2011
Date last updated
30/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The Slo-Niacin trial. A trial of phosphate lowering agent "slo-Niacin" in patients on haemodialysis.
Scientific title
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.
Secondary ID [1] 262131 0
Nil
Universal Trial Number (UTN)
U1111-1121-2212
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage renal failure. 265803 0
Chronic Kidney disease - mineral bone disorder. 265804 0
Hyperphosphataemia. 265805 0
Condition category
Condition code
Renal and Urogenital 265960 265960 0 0
Kidney disease
Metabolic and Endocrine 265961 265961 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 addition to usual baseline phosphate lowering therapy and haemodialysis prescription. Washout = 2 weeks. Completion of trial
Intervention code [1] 264547 0
Treatment: Drugs
Comparator / control treatment
Placebo (oral microcellulose capsule) in addition to usual baseline phosphate lowering therapy and haemodialysis prescription.
Control group
Placebo

Outcomes
Primary outcome [1] 266709 0
Serum phosphate, measured weekly
Timepoint [1] 266709 0
24 weeks (duration of trial)
Secondary outcome [1] 276231 0
Safety and tolerability of active treatment compared to placebo.

1. Presence of side effects attributable to niacin: flushing, intradialytic hypotension, gastrointestinal upset. Monitored weekly by patient assessment.

2. Presence of hepato-toxicity: liver funciton tests monitored weekly.
Timepoint [1] 276231 0
24 weeks (duration of trial)

Eligibility
Key inclusion criteria
1. Adult patients with end stage renal failure on maintenance haemodialysis.
2. Patients with hyperphosphataemia in context of the above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients unable to give informed consent.
2. Pregnant patients.
3. Patients enrolled in other trials of medication.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients educated about trial.
Patient information sheet given.
Recruitment after receipt of signed consent form.
Treatment allocation determined by off site investigator who performs the allocation process.
Treatment (placebo and active ) in identical containers.
Crossover trial structure, so patients will take both placebo and active treatment at different stages in the trial.
All patients will still be taking their usual background phosphate lowering medications (although no dose modifications of these will be permitted for the duration of the trial).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients allocated to either placebo treatment first or active treatment first in blocks (sealed envelopes). Aiming to recruit 32 patients total, based on acheiving power of 80% to detect a change in serum phosphate of 30%.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
1. Power calculation for sample size:
Based on the data from previous studies, we postulated that an effect size of 0.3mmol/L reduction in serum phosphate over 8 weeks was appropriate. Based on data from our unit on the inter-patient variability of serum phosphate over time, our estimated SD was 0.55mmol/L. Thus, to achieve 80% power at the 5% significance level, we required 27 patients. We assumed a drop-out rate of 20% and recruited 33 patients.

2. Paired T test.
3. Anova (one-way variance).
4. McNemar's test with Yates' correction for continuity.
5. Fisher's exact test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
22/06/2011
Date of last participant enrolment
Anticipated
Actual
26/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265049 0
Hospital
Name [1] 265049 0
Renal Unit, Princess Alexandra hosptial.
Country [1] 265049 0
Australia
Primary sponsor type
Individual
Name
Dr. Ken-Soon Tan
Address
Renal unit,
Logan hospital,
Cnr Armstrong and Loganlea roads,
Meadowbrook,
QLD, 4131.
Country
Australia
Secondary sponsor category [1] 264148 0
Individual
Name [1] 264148 0
Dr. James Petrie
Address [1] 264148 0
Renal unit,
Logan hospital,
Cnr Armstrong and Loganlea roads,
Meadowbrook,
QLD, 4131
Country [1] 264148 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267038 0
Metro South Human Research Ethics Committee.
Ethics committee address [1] 267038 0
Centres for Health Research,
Princess Alexandra Hospital,
Metro South Health Service District,
Ipswich road,
Woolloongabba,
QLD, 4102
Ethics committee country [1] 267038 0
Australia
Date submitted for ethics approval [1] 267038 0
17/08/2010
Approval date [1] 267038 0
10/01/2011
Ethics approval number [1] 267038 0
HREC/10/QPAH/083

Summary
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.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32582 0
Dr Ken-Soon Tan
Address 32582 0
Renal unit,
Logan hospital,
Cnr Armstrong and Loganlea Roads,
Meadowbrook,
QLD 4131,
Australia
Country 32582 0
Australia
Phone 32582 0
+61 7 30892049
Fax 32582 0
Email 32582 0
[email protected]
Contact person for public queries
Name 15829 0
Dr Dr. Ken-Soon Tan
Address 15829 0
C/o Renal unit,
Logan Hospital,
Cnr Armstrong and Loganlea roads,
Meadowbrook,
QLD, 4131.
Country 15829 0
Australia
Phone 15829 0
+ 61 7 3089 2049
Fax 15829 0
Email 15829 0
[email protected]
Contact person for scientific queries
Name 6757 0
Dr Dr. Ken-Soon Tan
Address 6757 0
C/o Renal unit,
Logan Hospital,
Cnr Armstrong and Loganlea roads,
Meadowbrook,
QLD, 4131.
Country 6757 0
Australia
Phone 6757 0
+ 61 7 3089 2049
Fax 6757 0
Email 6757 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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