CompletedPhase 3

Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

United States369 participantsStarted 2016-07

Plain-language summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. epoetin: \> 7700 units/dose three times per week or \>23,000 units per week
✕. Darbepoetin alfa: \>100 micrograms per week (mcg/week)
✕. methoxy polyethylene glycol-epoetin beta: \>100 micrograms (mcg) every other week or \>200 mcg/month

What they're measuring

Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)

Timeframe: Baseline; Weeks 24 to 36

Median Time to First Major Adverse Cardiovascular Event (MACE)

Timeframe: Up to 176 weeks

Trial details

NCT IDNCT02865850

SponsorAkebia Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-31

Results submitted2022-04-25

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