Evidence map›Paper›PMID 33732974›Full record

ArticleKidney international reports2021

Efficacy and Safety of a Novel Nicotinamide Modified-Release Formulation in the Treatment of Refractory Hyperphosphatemia in Patients Receiving Hemodialysis-A Randomized Clinical Trial.

Markus Ketteler, Andrzej Wiecek, Alexander R Rosenkranz, Andreas Pasch, Jan Rekowski, Burkhard Hellmann, Michael Karus, Richard Ammer

Open access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
    Trial
  5. Article
  6. Cholestyramine in hemodialysis: a new approach for hyperphosphatemia management.The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology · 2025
    Article
  7. Article
  8. Article
  9. Pharmacology of Mammalian NaHandbook of experimental pharmacology · 2024
    Article
  10. Article
  11. Article
  12. [Research Progress in Niacinamide in the Prevention and Treatment of Mouth and Systemic Diseases].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2023
    Review
  13. NADCells · 2022
    Review
  14. Article
  15. Nicotinamide and acute kidney injury.Clinical kidney journal · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 5 countries.

Markus KettelerRobert Bosch Hospital, Department of General Internal Medicine and Nephrology, Stuttgart, Germany.
Andrzej WiecekDepartment of Nephrology, Transplantation and Internal Medicine, Medical University of Silesia in Katowice, Poland.
Alexander R RosenkranzDivision of Nephrology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Andreas PaschCalciscon AG, Nidau, Switzerland.
Jan RekowskiInstitute for Medical Informatics, Biometry and Epidemiology, Essen University Hospital, Essen, Germany.
Burkhard HellmannMedical Department, MEDICE Arzneimittel Pütter GmbH & Co KG, Iserlohn, Germany.
Michael KarusMedical Department, MEDICE Arzneimittel Pütter GmbH & Co KG, Iserlohn, Germany.
Richard AmmerMedical Department, MEDICE Arzneimittel Pütter GmbH & Co KG, Iserlohn, Germany.
Medice (Germany) · DEInstitut für Medizinische Informatik, Biometrie und Epidemiologie · DELindenhofspital · CHMedical University of Graz · ATMedical University of Silesia · PLRobert Bosch Hospital · DEUniversity Hospital Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDespite widespread use of phosphate binders (PBs), phosphate control is insufficient in many hemodialysis patients. Preliminary clinical observations suggest that nicotinamide may act synergistically with PBs to improve phosphate control.

methodsThis multinational, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of nicotinamide modified release (NAMR) in combination with oral PB in a large cohort of hemodialysis patients with abnormal serum phosphate concentration (>4.5 mg/dl) despite treatment with PB. Patients entered a proof-of-efficacy phase (12 weeks [W12]) in which adjustments of relevant comedication were not permitted, followed by a safety extension phase for up to 52 weeks. Here, we report the results of the first phase.

resultsThe intention-to-treat (ITT) population consisted of 539 patients in the NAMR and 183 patients in the placebo group. NAMR and placebo were orally administered once daily (250-1500 mg/d). Mean age of patients was 61.8 years, and 63.0% were men. In the confirmatory analysis that estimated the difference in serum phosphate concentration after 12 weeks, NAMR proved superior over placebo with a significant difference of -0.51 mg/dl (95% confidence interval [CI] -0.72, -0.29;

conclusionNAMR combined with oral PB significantly improved phosphate control in hemodialysis patients.

Indexed as

hemodialysishyperphosphatemiamineral and bone diseasenicotinamidephosphate binder combination therapyrandomized controlled trial

Identifiers

PMID33732974
PMCPMC7938065
OpenAlexW3115076509

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.