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Phase 3, Randomized, Double-Blind, Active-Comparator (Darbepoetin Alfa) Study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan.

Author: AkizawaTadao, IwasakiManabu, MajikawaYoshikatsu, ReuschMichael, YamaguchiYusuke

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Equivalence TrialA clinical trial designed to show that a new treatment is equivalent in efficacy/safety to an existing treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, was found to be noninferior to darbepoetin alfa in maintaining hemoglobin levels within a target range of 10-12 g/dl in patients on hemodialysis for chronic kidney disease (CKD) anemia. The study involved 303 patients and lasted 24 weeks. Treatment-emergent adverse events were consistent with previous reports.
Paper Details　
Original Abstract of the Article :
BACKGROUND: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in China for dialysis-dependent CKD anemia. METHODS: This phase 3, 24-week, double-blind, double-dummy study evaluated roxadustat's noninferiority to darbepoetin alfa for hemodialysis-dependent CKD anem...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7350993/

データ提供：米国国立医学図書館（NLM）

Roxadustat: A Promising Oral Treatment for Anemia in Dialysis Patients

Anemia, a common complication in patients with chronic kidney disease (CKD), can significantly impact their quality of life. This research focuses on roxadustat, a novel oral medication, and its potential as an effective treatment for anemia in CKD patients on hemodialysis. The study meticulously compares the efficacy of roxadustat to darbepoetin alfa, a standard injectable treatment, employing a rigorous double-blind, randomized controlled trial design. Think of this research as a careful exploration of a vast desert of therapeutic options, seeking a safe and effective oral medication for anemia.

The study found that roxadustat was noninferior to darbepoetin alfa in maintaining hemoglobin levels within a desired range. This finding indicates that roxadustat is a viable and potentially more convenient alternative for patients on hemodialysis, offering a promising option for managing anemia without the inconvenience of injections.

A New Horizon for Anemia Treatment: Roxadustat's Promise

This research highlights the potential of roxadustat as a safe and effective oral treatment for anemia in CKD patients on hemodialysis. The study's findings offer a glimmer of hope for patients seeking a more convenient and less invasive approach to managing anemia.

Navigating the Desert of Anemia: A More Convenient Path

The desert of anemia can be a challenging landscape for CKD patients on hemodialysis, often requiring frequent injections to manage the condition. This research offers a potential oasis, showcasing roxadustat's potential as a safe and effective oral treatment, providing a more convenient and less invasive path toward better health.

Dr. Camel's Conclusion

This study provides compelling evidence for roxadustat's efficacy and safety as an oral treatment for anemia in CKD patients on hemodialysis, offering a promising alternative to traditional injectable therapies.

Date :
  1. Date Completed 2021-02-24
  2. Date Revised 2023-01-23
Further Info :

Pubmed ID

32493693

DOI: Digital Object Identifier

PMC7350993

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・Effects of darbepoetin alfa injection
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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