Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001229763
Ethics application status
Approved
Date submitted
29/10/2013
Date registered
8/11/2013
Date last updated
8/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of the effect of Niacinamide on Fibroblast Growth factor 23 (FGF23) levels in Chronic Kidney Disease.
Scientific title
A randomised, double-blind, placebo-controlled trial to assess the effect of niacinamide on levels of Fibroblast Growth factor 23 (FGF23) in patients with chronic kidney disease stages 3b-4.
Secondary ID [1] 283474 0
Nil Known
Universal Trial Number (UTN)
U1111-1146-6508
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elevated levels of FGF23 in chronic kidney disease 290388 0
Condition category
Condition code
Renal and Urogenital 290781 290781 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Niacinamide (500mg 4 x daily)
Administration: oral capsules
Duration of treatment: 16 weeks
Adherence will be monitored by count of remaining capsules at each trial visit every 4 weeks
Intervention code [1] 288185 0
Treatment: Drugs
Comparator / control treatment
Matched placebo (500mg 4 x daily)
Administration: oral capsules
Duration of treatment: 16 weeks

Placebo (maltodextrin) that is indistinguishable from the active treatment but containing no active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 290777 0
Change in serum intact FGF23 (measured by Kainos hFGF-23 Elisa assay)
Timepoint [1] 290777 0
At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary outcome [1] 305264 0
Serum phosphate
Timepoint [1] 305264 0
At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary outcome [2] 305265 0
24 hour urinary phosphate
Timepoint [2] 305265 0
At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary outcome [3] 305389 0
Serum parathyroid hormone (PTH)
Timepoint [3] 305389 0
At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary outcome [4] 305390 0
estimated Glomerular Filtration rate (eGFR)
Timepoint [4] 305390 0
At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary outcome [5] 305391 0
Serum high-density lipoprotein (HDL)
Timepoint [5] 305391 0
At baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks

Eligibility
Key inclusion criteria
1. Patients with Chronic Kidney Disease (CKD) Stages 3b-4 (eGFR between 15-45ml/ min/1.73m2)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study
2. Medical conditions that impact on phosphate metabolism (apart from CKD), eg. primary hyperparathyroidism or hypoparathyroidism; previous subtotal parathyroidectomy; gastrointestinal malabsorption disorders such as Crohn’s disease, ulcerative colitis, coeliac disease or severe liver dysfunction
3. Treatment with any drug that could impact on mineral metabolism
4. Treatment with anti-epileptic drugs
5. Treatment with anticoagulants
6. Renal transplantation
7. Rapid changes of residual renal function
8. Serum PTH greater than 50 pmol/L
9. Serum albumin less than 30g/L
10. Active malignancy
11. Pregnancy or breast feeding

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)
Allocation by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation by the use of sequentially numbered opaque sealed envelopes for each trial cohort.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A randomised double blind, double dummy, placebo-controlled trial
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
For sample size considerations, we used published literature reporting repeated measures of FGF23. Based on published data, we assume the mean (SD) FG23 to be 72 (39) RU/mL in the control group. Based on a reduction in FGF23 of 33% we assume the mean (SD) FGF23 to be 48 (39) RU/mL in the experimental group, which is a clinically important and detectable difference. We have assumed an overall correlation between baseline and follow-up measurements of 0.7 based on a number of studies, but have also tested the sensitivity of power calculations using modelled correlation values of 0.1 and 0.9. Modelling these assumptions using repeated-measures analysis of covariance (ANCOVA), allowing for a 25% drop-out rate, and using a correlation value of 0.7, treatment groups of 18 would provide adequate power (power 0.9, 2-sided alpha 0.05). When correlation values of 0.1 or 0.9 are assumed sufficient treatment groups are 22 and 7 respectively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 5542 0
New Zealand
State/province [1] 5542 0

Funding & Sponsors
Funding source category [1] 288180 0
Charities/Societies/Foundations
Name [1] 288180 0
The Auckland Medical Research Foundation
Country [1] 288180 0
New Zealand
Primary sponsor type
Individual
Name
Christopher Hood
Address
Renal Department
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 286903 0
None
Name [1] 286903 0
Address [1] 286903 0
Country [1] 286903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290092 0
New Zealand Health and Disability Ethics Committees
Ethics committee address [1] 290092 0
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 290092 0
New Zealand
Date submitted for ethics approval [1] 290092 0
Approval date [1] 290092 0
22/10/2013
Ethics approval number [1] 290092 0
13/STH/124

Summary
Brief summary
The primary goal of this study is to determine if treatment with niacinamide will reduce levels of FGF23 in patients with CKD. FGF23 is elevated in CKD and has been associated with left ventricular hypertrophy and cardiac death. Low phosphate diet and phosphate binders have been shown to reduce levels of FGF23. If niacinamide is shown to successfully reduce FGF23 levels it will provide an easier "real world" approach to the early treatment of the mineral and bone disorder associated with CKD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43926 0
Dr Christopher Hood
Address 43926 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 43926 0
New Zealand
Phone 43926 0
+64 9 276 0000
Fax 43926 0
Email 43926 0
[email protected]
Contact person for public queries
Name 43927 0
Dr Christopher Hood
Address 43927 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 43927 0
New Zealand
Phone 43927 0
+64 9 276 0000
Fax 43927 0
Email 43927 0
[email protected]
Contact person for scientific queries
Name 43928 0
Dr Christopher Hood
Address 43928 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 43928 0
New Zealand
Phone 43928 0
+64 9 276 0000
Fax 43928 0
Email 43928 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.