CompletedPhase 2

16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis

United States94 participantsStarted 2014-09-10

Plain-language summary

The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.

Who can participate

Age range

18 Years – 79 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: * 18 to 79 years inclusive * Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months * Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous iron Key Exclusion Criteria: * Body mass index \>44.0 kilograms per meter squared (kg/m\^2) * Transfusion within 8 weeks prior to Screening * Alanine transaminase or total bilirubin \>1.25x ULN * Uncontrolled hypertension * Class III or IV congestive heart failure * Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack within 6 months prior to Screening

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 From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average

Timeframe: Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8

Change From Pre-dose Average in Hgb Level to The End-of-study Average

Timeframe: Pre-dose, Week 15, and Week 16

Change From Mid-study Average in Hgb Level to The End-of-study Average

Timeframe: Week 7, Week 8, Week 15, and Week 16

Trial details

NCT IDNCT02260193

SponsorAkebia Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07-22

Results submitted2022-04-22

View on ClinicalTrials.gov More Anemia trials