Evidence map›Paper›PMID 31619187›Full record

Trial reportBMC nephrology2019

A randomized, 29-day, dose-ranging, efficacy and safety study of daprodustat, administered three times weekly in patients with anemia on hemodialysis.

Christine K Bailey, Stephen Caltabiano, Alexander R Cobitz, Chun Huang, Kelly M Mahar, Vickas V Patel

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02689206 (A 29-day, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Switched From a Stable Dose of an Erythropoiesis-stimulating Agent), which is not on this map. Cited by 22 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 5 pooled it
3.4field-weighted citation impact, top 7% 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.

NCT02689206 phase2completednot on this map

A 29-day, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Switched From a Stable Dose of an Erythropoiesis-stimulating Agent

TypeinterventionalSponsorGlaxoSmithKlineRan2016 to 2017Enrolled103ConditionsAnaemiaArmsGSK1278863, GSK1278863 matching Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Navigating Anemia Therapy in CKD With Hypoxia-Inducible Factor Activators: A Review.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2026
    Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Daprodustat.Hospital pharmacy · 2023
    Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review
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

6 authors at 1 institution in 1 country.

Christine K BaileyR&D, Clinical Sciences, GlaxoSmithKline, 1250 S. Collegeville Road, Mail Code UP 4200, Collegeville, PA, 19426, USA. christine.k.bailey@gsk.com.
Stephen CaltabianoR&D, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.
Alexander R CobitzR&D, Clinical Sciences, GlaxoSmithKline, 1250 S. Collegeville Road, Mail Code UP 4200, Collegeville, PA, 19426, USA.
Chun HuangR&D, Clinical Statistics, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.
Kelly M MaharR&D, Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.
Vickas V PatelR&D, Discovery Medicine, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.
GlaxoSmithKline (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDaprodustat is a hypoxia-inducible factor-prolyl hydroxylase inhibitor currently being investigated as a treatment for anemia of chronic kidney disease (CKD) in both dialysis and nondialysis patients. In clinical studies to date, daprodustat has been administered orally as a once-daily regimen. This randomized, double-blind, placebo-controlled study characterized the initial dose-hemoglobin response as well as the efficacy and safety of three times weekly (TIW) daprodustat in hemodialysis patients switched from stable recombinant human erythropoietin (rhEPO), in accordance with a TIW hemodialysis schedule.

methods103 patients on hemodialysis with baseline hemoglobin of 9.0 to 11.5 g/dL and previously receiving a stable dose of rhEPO or its analogs were randomized 1:1:1:1:1 to receive daprodustat 10, 15, 25, or 30 mg or placebo TIW over 29 days.

resultsMean baseline hemoglobin was 10.6 g/dL for the placebo group and each daprodustat cohort. Daprodustat produced dose-dependent changes in mean hemoglobin from baseline to day 29. Using a Bayesian approach, the estimated dose conversion ratio between once-daily and TIW daprodustat was ~ 2.0 across the evaluated dose range using an E

conclusionsThese data help inform the appropriate dose conversion ratio to be applied to daily doses to obtain equivalent daprodustat TIW doses and suggest TIW treatment with daprodustat can treat anemia of CKD safely, supporting future long-term studies for this indication using a TIW dosing regimen.

trial registrationClinicalTrials.gov Identifier: NCT02689206 ; date registered: 02/11/2016.

Indexed as

AgedAged, 80 and overAnemiaBarbituratesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleEnzyme InhibitorsErythropoietinFemaleFerritinsGlycineHematinicsHematopoiesisHemoglobinsHepcidinsBarbituratesEnzyme InhibitorsErythropoietinFerritinsGlycineGSK1278863HematinicsHemoglobinsHepcidinsHypoxia-Inducible Factor-Proline DioxygenasesTransferrinVascular Endothelial Growth Factor AVEGFA protein, humanAnemiaBayesianClinical trialsDose responseEfficacyHemodialysisSafetyThree-times weekly (TIW)

Identifiers

PMID31619187
PMCPMC6796426
OpenAlexW2980991992

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.