ArticleKidney international reports2018
An Exploratory Study of Daprodustat in Erythropoietin-Hyporesponsive Subjects.
Article in Kidney international reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02075463 (A 16-week, Phase 2a, Single-arm, Multi-center, Open-label Study to Evaluate the Safety and Efficacy of GSK1278863 After Switching From Recombinant Human Erythropoietin), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
A 16-week, Phase 2a, Single-arm, Multi-center, Open-label Study to Evaluate the Safety and Efficacy of GSK1278863 After Switching From Recombinant Human Erythropoietin (rhEPO), in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Chronically Hyporesponsive to rhEPO
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effect of hypoxia-inducible factor-prolyl hydroxylase inhibitors on anemia in patients with CKD: a meta-analysis of randomized controlled trials including 2804 patients.Renal failure · 2020Pooled it
- KDIGO 2026 Clinical Practice Guideline for Anemia in Chronic Kidney Disease (CKD): a commentary from the European Renal Best Practice (ERBP).Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026Article
- Observational
- Effects of Individualized Anemia Therapy on Hemoglobin Stability: A Randomized Controlled Pilot Trial in Patients on Hemodialysis.Clinical journal of the American Society of Nephrology : CJASN · 2024Article
- Short-term effect of low-dose roxadustat combined with erythropoiesis-stimulating agent treatment for erythropoietin-resistant anemia in patients undergoing maintenance hemodialysis.Frontiers in endocrinology · 2024Article
- What Is the Role of Daprodustat in Treatment of Anemia in People on Maintenance Dialysis?Clinical journal of the American Society of Nephrology : CJASN · 2023Article
- A Novel Combination Therapy of Erythropoietin and Thrombopoietin to Treat Erythropoietin-Resistance anemia.Pharmaceutical research · 2022Article
- Erythropoietin-Stimulating Agent Hyporesponsiveness in Patients Living with Chronic Kidney Disease.Kidney diseases (Basel, Switzerland) · 2022Review
- Challenging patient phenotypes in the management of anaemia of chronic kidney disease.International journal of clinical practice · 2021Review
- Roxadustat for renal patients with hyporesponsiveness to ESAs: a new opportunity?Internal and emergency medicine · 2021Article
- Anemia management for home dialysis including the new US public policy initiative.Kidney international supplements · 2021Article
- Iron metabolism and management: focus on chronic kidney disease.Kidney international supplements · 2021Article
- Hypoxia-inducible factor-prolyl hydroxylase inhibitors in the treatment of anemia of chronic kidney disease.Kidney international supplements · 2021Article
- Roxadustat in treating anemia in dialysis patients (ROAD): protocol and rationale of a multicenter prospective observational cohort study.BMC nephrology · 2021Article
- Hypoxia-Inducible Factor-Proline Hydroxylase Inhibitor in the Treatment of Renal Anemia.Kidney diseases (Basel, Switzerland) · 2021Review
- Burden of Anemia in Chronic Kidney Disease: Beyond Erythropoietin.Advances in therapy · 2021Review
- Hypoxia-Inducible Factor Activators in Renal Anemia: Current Clinical Experience.Advances in chronic kidney disease · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHyporesponsiveness to recombinant human erythropoietin (rhEPO) is a major problem affecting some patients with chronic kidney disease (CKD), predominantly those on hemodialysis (HD). Daprodustat (GSK1278863) is a hypoxia-inducible factor prolyl hydroxylase inhibitor that is being investigated as a treatment for anemia of CKD.
methodsThis phase 2a, exploratory, multicenter, single-arm study assessed the ability of daprodustat to increase or maintain hemoglobin concentrations within the target range (10.0-11.5 g/dl) over 16 weeks in subjects with anemia who were on HD and who had a high erythropoietin resistance index (ERI). All included subjects met the criteria for chronic rhEPO hyporesponsiveness (i.e., an ERI based on a series of contiguous strata of patients' hemoglobin-by-epoetin alfa for a minimum of 12 weeks). Eligible adults were on a stable HD regimen 3 to 4 times per week. Markers of iron utilization and safety were also assessed. All subjects initially received oral daprodustat 12 mg once daily.
resultsOf the 60 participants screened, 15 were enrolled, and 7 (47%) completed 16 weeks of treatment. At week 16, 2 of 7 subjects (29%) had >1 g/dl increases in hemoglobin from baseline. Daprodustat had minimal effects on markers of iron metabolism and utilization. Fourteen subjects (93%) experienced ≥1 adverse event (AE). The most common AEs included nausea, pneumonia, pleural effusion, and urinary tract infection. The majority of on-therapy AEs were mild or moderate in intensity.
conclusionDaprodustat increased hemoglobin concentrations within the target range in 29% of chronic rhEPO-hyporesponsive subjects. No new safety concerns were identified in this short exploratory study.
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