Trial reportBMC nephrology2019
Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial.
Trial report in BMC nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05699109 (Short Versus Long-Acting Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled 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.
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.
Short Versus Long-Acting Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Efficacy and safety analysis of different treatment schemes of erythropoiesis-stimulating agents for chronic kidney disease with anemia: a meta analysis between 2000-2024.BMC nephrology · 2026Pooled it
- Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- Comparative effectiveness and acceptability of HIF prolyl-hydroxylase inhibitorsFrontiers in pharmacology · 2023Pooled it
- Phase-targeted erythropoietin derivatives for traumatic brain injury: bridging mechanisms to precision therapy.Frontiers in neurology · 2025Review
- Short versus long-acting erythropoiesis-stimulating agents for anemia management in Egyptian hemodialysis patients.Qatar medical journal · 2024Article
- Review
- Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open-label, parallel-group, noninferiority phase III trial.Chronic diseases and translational medicine · 2022Article
- Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail.Chronic diseases and translational medicine · 2022Article
- Hypothermia combined with neuroprotective adjuvants shortens the duration of hospitalization in infants with hypoxic ischemic encephalopathy: Meta-analysis.Frontiers in pharmacology · 2022Review
- Challenging patient phenotypes in the management of anaemia of chronic kidney disease.International journal of clinical practice · 2021Review
- Article
- Comparative effectiveness of erythropoietin alpha and beta in hemodialysis patients: a single-center prospective observational study.Journal of community hospital internal medicine perspectives · 2021Article
- Burden of Anemia in Chronic Kidney Disease: Beyond Erythropoietin.Advances in therapy · 2021Review
- Improving the Pharmacodynamics and In Vivo Activity of ENPP1-Fc Through Protein and Glycosylation Engineering.Clinical and translational science · 2021Article
- Review
- Correlation between haemoglobin level and type of erythropoiesis-stimulating agent at initiation of haemodialysis.International journal of clinical pharmacy · 2020Observational
- Article
Corrections and comments
- Erratum issued
Authors and funding
10 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDarbepoetin alfa (DA-α) is a long-acting erythropoiesis-stimulating glycoprotein which has half-life three-fold longer than that of Erythropoietin alfa (EPO). The objective of this study was to compare the efficacy and safety of DA-α injection versus EPO for treating renal anemia amongst Indian patients with end-stage renal disease (ESRD) undergoing dialysis.
methodsPatients of either gender (aged 18-65 years) with ESRD undergoing dialysis who had hemoglobin (Hb) levels < 10 g/dL after receiving EPO were switched to DA-α (0.45 μg/kg) once weekly subcutaneously or EPO 50 IU/kg thrice weekly subcutaneously (centrally randomized 1:1) for 12-24 weeks (correction phase) followed by 12 weeks maintenance phase (for Hb levels ≥10 g/dL). The primary efficacy endpoint was mean change in Hb level from baseline to end of correction phase.
resultsIn the intention-to-treat population (n = 126), the between group difference in mean Hb change was - 0.01 g/dL (95% CI - 0.68 to - 0.66, p = 0.97). After adjusting for covariates, the difference was - 0.2878 g/dL (95% CI -0.936 to0.360). The lower limit of the two-sided 95% CI of primary endpoint was above the pre-specified non-inferiority margin of - 1.0 g/dL. Similar trend of non-inferiority was observed for per-protocol population. Safety profile of DA-α and EPO were observed to be similar.
conclusionOur study results demonstrated that for patients with ESRD undergoing dialysis, administering DA-α at lower dose frequency, is equally effective and well tolerated as EPO for treating renal anemia.
trial registrationCTRI/2012/07/002835 [Registered on: 27/07/2012]; Trial Registered Prospectively.
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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.