Trial reportAdvances in therapy2023
Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies.
Trial report in Advances in therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 17 papers.
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.
A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-Dialysis Patients
A Phase 3, Multicenter, Randomized, Open-label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients
A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects With End Stage Renal Disease (ESRD) on Stable Dialysis
Who cites it
17 citing papers in PubMed, 22 citations in OpenAlex.
- Roxadustat and incidence of peritoneal dialysis-associated peritonitis: a propensity score-matched cohort study.Clinical and experimental nephrology · 2026Article
- Inflammation and Erythropoietin Resistance in Chronic Kidney Disease: A Cross-Sectional Study of C-Reactive Protein and Anemia in Hemodialysis Patients.Journal of clinical laboratory analysis · 2026Article
- Effect of Roxadustat on Cardiometabolism in Healthy Individuals (ROXACardioMeta): Protocol for a Double-Blind, Placebo-Controlled and Randomised Cross-Over Trial.Methods and protocols · 2026Article
- Comparative efficacy and safety of methoxy polyethylene glycol-epoetin beta and roxadustat in the management of renal anemia in maintenance hemodialysis.Frontiers in pharmacology · 2026Article
- Roxadustat as a Hypoxia-Mimetic Agent: Erythropoietic Mechanisms, Bioanalytical Detection, and Regulatory Considerations in Sports Medicine.Current issues in molecular biology · 2025Review
- Anemia and iron deficiency in post-kidney transplantation: an unsolved challenge.Clinical kidney journal · 2025Review
- Roxadustat for CKD-related anemia: a unified solution for non-dialysis, dialysis, and post-transplant patients.International urology and nephrology · 2025Article
- Effects of hypoxia-inducible factor prolyl hydroxylase inhibitors on hemoglobin, B-type natriuretic peptide, and renal function in anemic heart failure patients: A systematic review andInternational journal of cardiology. Heart & vasculature · 2025Article
- Efficacy and Safety of Roxadustat in Patients with CKD: Pooled Analysis by Baseline Inflammation Status.Journal of clinical medicine · 2025Article
- Roxadustat for renal anemia: current clinical experience.Frontiers in pharmacology · 2025Review
- Total loss ofProceedings of the National Academy of Sciences of the United States of America · 2024Article
- Review
- Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors as a New Treatment Option for Anemia in Chronic Kidney Disease.Biomedicines · 2024Review
- A novel scenario in the therapeutic management of anemia of chronic kidney disease: placement and use of roxadustat.Journal of nephrology · 2024Review
- Consensus commentary and position of the Italian Society of Nephrology on KDIGO controversies conference on novel anemia therapies in chronic kidney disease.Journal of nephrology · 2024Article
- Pregnancy in patients with chronic kidney disease undergoing dialysis.Jornal brasileiro de nefrologiaReview
- Comparative Effectiveness and Safety of Roxadustat versus Erythropoiesis-Stimulating Agents in Patients Receiving Maintenance Hemodialysis: A Real-World Cohort Study.Kidney diseases (Basel, Switzerland)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis study was conducted to elucidate the safety of roxadustat, an oral medication, in patients with non-dialysis-dependent (NDD) or incident dialysis dialysis-dependent (ID-DD) chronic kidney disease (CKD).
methodsSafety results from four phase 3, randomized, open-label studies comparing roxadustat to an erythropoiesis-stimulating agent (ESA) in men and women with NDD or ID-DD CKD with anemia were pooled and evaluated. Endpoints were time to major adverse cardiovascular event (MACE; myocardial infarction, stroke, and all-cause mortality) and MACE+ (MACE plus congestive heart failure or unstable angina requiring hospitalization), all-cause mortality, and treatment-emergent adverse events (TEAEs). MACE and MACE+ were evaluated for non-inferiority at 1.8- and 1.3-margins using hazard ratios (HRs) and 95% confidence intervals (CIs). TEAEs were descriptively summarized.
resultsIn total, 2142 patients were evaluated (1083 roxadustat; 1059 ESA). Roxadustat was comparable to ESA for risk of MACE (HR 0.79, 95% CI 0.61-1.02), MACE+ (HR 0.78, 95% CI 0.62-0.98), and all-cause mortality (HR 0.78, 95% CI 0.57-1.05). TEAEs were comparable between roxadustat and ESA groups, including any TEAE [incidence rate per 100 (IR/100) patient-exposure years 56.1 vs. 53.5], TEAEs leading to study drug discontinuation (IR/100 patient-exposure years 6.7 vs. 5.1), and TEAEs leading to death (IR/100 patient-exposure years 6.9 vs. 7.4).
conclusionThere was no evidence of increased risk of cardiovascular events or mortality with roxadustat compared with ESA in patients with anemia who have NDD or ID-DD CKD. Although TEAEs occurred commonly in both the roxadustat and ESA groups, patients infrequently discontinued the study drug because of an adverse event. CLINICAL TRIAL REGISTRATION NUMBERS: DOLOMITES, 1517-CL-0610 [NCT02021318]; HIMALAYAS, FGCL-4592-063 [NCT02052310]; SIERRAS, FGCL-4592-064 [NCT02273726]; and ROCKIES, D5740C00002 [NCT02174731].
Indexed as
Identifiers
What OpenQuestion holds
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.