Not Yet RecruitingPhase 4

Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis Patients

40 participantsStarted 2026-04-15

Plain-language summary

This is a two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. All participants remain on background darbepoetin alfa therapy throughout the study. The study compares add-on vadadustat plus background darbepoetin alfa with background darbepoetin alfa alone, with each treatment period lasting 8 weeks and separated by a 4-week washout period. Monthly laboratory assessments and dialysis adequacy measurements will be performed to evaluate anemia control, quality of life, inflammation, and dialysis adequacy.

Who can participate

Age range18 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.

Inclusion Criteria: * Age 18 years or older * Receiving maintenance peritoneal dialysis * Followed at the outpatient clinics of MacKay Memorial Hospital * Receiving background darbepoetin alfa therapy * Able and willing to provide informed consent Exclusion Criteria: * Blood pressure \>170/80 mmHg on three separate occasions * Recent cardiovascular events within the past 3 months, including coronary artery disease, myocardial ischemia, cerebrovascular disease, or peripheral artery disease * Gastrointestinal bleeding within the past 3 months * Active malignancy

What they're measuring

Change in Hemoglobin

Timeframe: Baseline and end of each 8-week treatment period (up to 5 months).

Trial details

NCT IDNCT07537816

SponsorMackay Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

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