Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatmen… (NCT04484857) | Clinical Trial Compass
CompletedPhase 3
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
United States283 participantsStarted 2020-07-22
Plain-language summary
The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.
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.
Key Inclusion Criteria:
* Receiving chronic dialysis for end stage renal disease (ESRD)
* Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunnelled catheter
* Screening Hb criteria: Participants converting from an ESA: between 9.0 to 12.0 grams (g)/deciliter (dL); Participants initiating anemia treatment: \< 10.0 g/dL
* Ferritin ≥ 50 nanograms (ng)/mililiter (mL), Transferrin saturation (TSAT) ≥ 10% at screening
* 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 at screening and prior to initiating roxadustat treatment.
* Body weight between 45.0 to 160.0 kg
Key Exclusion Criteria:
* Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
* Known history of myelodysplastic syndrome or multiple myeloma
* Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
* Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
* Active or chronic gastrointestinal bleeding
* Treated with iron-chelating agents within 4 weeks prior to enrollment
* History of New York Heart Association (NYHA) Class III or IV congestive heart failure
* History of myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular di…
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
1
Percentage of Participants With Mean Hb Value ≥10 g/dL
Timeframe: Week 16 through Week 24
2
Mean Hb Change From Baseline to Average Hb From Weeks 16-24