Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Ketteler, M; Wiecek, A; Rosenkranz, AR; Ose, C; Rekowski, J; Lorenz, H; Hellmann, B; Karus, M; Ruhmann, M; Ammer, R.
Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase III randomised controlled NOPHOS trial.
Nephrol Dial Transplant. 2022;
Doi: 10.1093/ndt/gfac206
[OPEN ACCESS]
Web of Science
PubMed
FullText
FullText_MUG
- Co-authors Med Uni Graz
- Rosenkranz Alexander
- Altmetrics:
- Dimensions Citations:
- Plum Analytics:
- Scite (citation analytics):
- Abstract:
- BACKGROUND: We previously reported that modified-release nicotinamide (NAMR) was superior to placebo in reducing serum phosphate concentrations over 12 weeks in a large cohort of haemodialysis patients with hyperphosphataemia. Here, we report outcomes after 52 weeks of treatment. METHODS: NOPHOS was a phase III, international, randomised, controlled, double-blind trial in parallel group design. NAMR (250-1500 mg/d) was investigated in comparison to placebo as an add-on therapy to an individual therapy with approved phosphate binders. RESULTS: In the intention-to-treat population (NAMR: N = 539, placebo: N = 183), serum phosphate was significantly lower in the NAMR group compared to the placebo group at W24 (5.40 ± 1.55 mg/dl vs. 5.79 ± 1.37 mg/dl, P < 0.001) with a mean difference of -0.39 mg/dl [95% CI -0.66, -0.13], but was comparable between the groups at W52 (mean difference -0.08 [95% CI -0.36, 0.20]). In the completer population (N = 358), statistical significance in favour of NAMR was reached at W24 and W52. The treatment effect was reduced in patients with high baseline serum intact parathyroid hormone (iPTH) compared to patients with low baseline serum iPTH. Compliant patients in the NAMR group had a more pronounced and sustained reduction in serum phosphate than non-compliant patients. NAMR treatment was associated with a significantly increased risk of thrombocytopenia, pruritus, anaemia, and diarrhoea. Herpes zoster occurred exclusively in patients randomised to NAMR. CONCLUSIONS: NAMR combined with phosphate binders significantly reduced serum phosphate over the first 24 weeks of treatment, but the treatment effect was not maintained up to W52. Non-compliance may have contributed to reduced long-term efficacy. Several newly identified safety signals warrant further evaluation.
- Find related publications in this database (Keywords)
- haemodialysis
- hyperphosphataemia
- mineral and bone disease
- nicotinamide
- randomized controlled trial