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Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Patients on Stable Dialysis

NCT02278341•Astellas Pharma Europe B.V.

View on ClinicalTrials.gov

Summary

This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

Detailed Description

This study consisted of three study periods as follows: * Screening Period: up to 6 weeks * Treatment Period: a minimum of 52 weeks up to a maximum of 104 weeks * Follow-up Period: 4 weeks

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Main Inclusion:
•Participant is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to randomization.
•Participant is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks prior to randomization with stable weekly doses (during 4 weeks prior to randomization).
•Mean of the participant's three most recent Hb values, as measured by central laboratory, during the Screening Period.
•Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN

Exclusion Criteria

•Main Exclusion:
•Participant has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization.
•Participant has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than Chronic Kidney Disease (CKD).
•Participant has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
•Participant has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization.
•Participant has a history of malignancy, except for the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
•Participant has had any prior organ transplant (that has not been explanted), or participant is scheduled for organ transplantation.

Locations (143)

Site BE32004

Brussels, Flemish Brabant, Belgium

Site BE32001

Aalst, Belgium

Site BE32019

Antwerp, Belgium

Site BE32002

Antwerp, Belgium

Site BE32012

Baudour, Belgium

Site BE32017

Bonheiden, Belgium

Site BE32003

Leuven, Belgium

Site BE32013

Liège, Belgium

Site BE32011

Roeselare, Belgium

Site BG35925

Blagoevgrad, Bulgaria

Key Dates

Start Date

November 21, 2014

Primary Completion Date

June 8, 2017

Completion Date

July 6, 2018

Last Updated

November 27, 2024

Enrollment

838

ACTUAL participants

Conditions

AnemiaEnd Stage Renal Disease (ESRD)

Interventions

Roxadustat

DRUG

Epoetin alfa

DRUG

Darbepoetin alfa

DRUG

Iron

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

Inclusion Criteria

Exclusion Criteria

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