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 range18 Years – 79 Years

SexALL

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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

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

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