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April 4, 2022Frontiers in MedicineOpen Access

Planned trial tests roxadustat against erythropoietin to improve heart function in cardiorenal-anemia syndrome.

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Why the study?

Patients with chronic kidney disease are at high risk of type 4 cardiorenal-anemia syndrome, which worsens kidney and heart function and increases mortality, and the efficacy and safety of roxadustat in treating type 4 CRAS are unknown.

Does roxadustat improve heart function compared to erythropoietin in patients with type 4 cardiorenal-anemia syndrome?

Population

68 patients diagnosed with type 4 cardiorenal-anemia syndrome

Comparison

Roxadustat vs erythropoietin

Design

Randomized open-label controlled trial

Follow-up

24 weeks

Key result

Roxadustat will be evaluated against erythropoietin for its ability to improve heart function in 68 patients with type 4 cardiorenal-anemia syndrome in this planned randomized controlled trial.

Authors

YXYang XuHTHui TianSJS Jiang

Discussion

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Overview

Planned RCT addresses evidence gap in type 4 cardiorenal-anemia syndrome; leaves open whether roxadustat improves heart function over erythropoietin.

Study Design

Type

RCT (n=68)

Blinding

Open-label

Randomization

Computer-generated sequence (1:1 ratio)

Multicenter

No

Structured PICO

Does roxadustat improve heart function compared to erythropoietin in patients with type 4 cardiorenal-anemia syndrome?

P
Population
68 adult patients with type 4 cardiorenal-anemia syndrome, non-dialysis CKD stage 3a-5, and hemoglobin 70-100 g/L, to be followed for 24 weeks of treatment.
I
Intervention
Roxadustat with an initial dose of 70 or 100 mg three times a week for 24 weeks
C
Comparator
Subcutaneous injection of erythropoietin for 24 weeks, to maintain a hemoglobin ranging from 100 to 120 g/L
O
Outcome
Change in heart function, including brain natriuretic peptide (BNP), 6-min walk test (6-WT), and left ventricular ejection fraction (LVEF)surrogate

This study protocol outlines a randomized trial to evaluate the efficacy and safety of roxadustat compared to erythropoietin for improving heart function in patients with type 4 cardiorenal-anemia syndrome.

Limitations

  • The study is single-centered and open-labeled, indicating there might be increased bias.
  • The short study duration of 36 weeks means primary outcomes only include surrogate endpoints rather than hard clinical endpoints like mortality.

Cite This Study

Xu et al. (2022) conducted an RCT in Type 4 Cardiorenal-Anemia Syndrome (n=68). Roxadustat vs. Erythropoietin was evaluated on Change in brain natriuretic peptide (BNP), 6-min walk test (6-WT), and left ventricular ejection fraction (LVEF) from baseline to 24 weeks. Roxadustat will be evaluated against erythropoietin for its ability to improve heart function in 68 patients with type 4 cardiorenal-anemia syndrome in this planned randomized controlled trial.

synapsesocial.com/papers/6aabbeedbf7b76dfa683530bhttps://doi.org/10.3389/fmed.2022.783387
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Effect of Roxadustat on Cardiometabolism in Healthy Individuals (ROXACardioMeta): Protocol for a Double-Blind, Placebo-Controlled and Randomised Cross-Over Trial2026
  2. 2Roxadustat for CKD-related anemia in patients undergoing peritoneal dialysis: a systematic review and meta-analysis2026
  3. 3A retrospective study on the efficacy of Roxadustat in peritoneal dialysis patients with erythropoietin hyporesponsiveness2024 · 1 citations
  4. 4The Efficacy and Safety of Roxadustat for the Treatment of Posttransplantation Anemia: A Randomized Study2024 · 19 citations
  5. 5#535 Roxadustat as a treatment of anemia after kidney transplantation2024