CompletedNot Applicable

Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related Anemia

Egypt35 participantsStarted 2024-06-01

Plain-language summary

Anemia is a common and debilitating complication of end-stage kidney disease (ESKD) that is associated with reduced quality of life and high morbidity and mortality. ESKD-related anemia is associated with many adverse comorbidities and outcomes; however, normalizing the levels of hemoglobin proved to be insignificant in improving most adverse outcomes. This study aims to evaluate the real-world effectiveness and safety of an ESA and a HIF-PHI in patients with CKD-related anemia.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * End-stage kidney disease-related anemia * Hemodialysis-related anemia * The mean of the two most recent Hemoglobin values before randomization was 10.5mg/dL or less Exclusion Criteria: * ESA treatment 12 weeks before transfusion * RBC transfusion 8 weeks before transfusion * IV iron transfusion 6 weeks before transfusion * Known history of myelodysplastic syndrome * Known history of multiple myeloma * Known history of hereditary hematologic diseases * Active bleeding or any cause of anemia unrelated to CKD * NYHA Class III or IV congestive heart failure * Liver disease, defined as ALT or AST 3x ULN or greater, or total bilirubin 1.5x ULN or greater * Prior organ transplant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Iron profile

Timeframe: 12 weeks

Trial details

NCT IDNCT07517744

SponsorAin Shams University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-12

View on ClinicalTrials.gov More CKD Anemia trials