A randomised control trial of the effect of Niacinamide on Fibroblast Growth factor 23 (FGF23) levels in Chronic Kidney Disease.

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001229763

Enrollment

Registered

2013-11-08

Start date

2014-01-07

Completion date

Unknown

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

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with Chronic Kidney Disease (CKD) Stages 3b-4 (eGFR between 15-45ml/ min/1.73m2)

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

Outcome results