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

NCT07537816 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Renal Anemia

Interventions

DRUG

Vadadustat

Vadadustat administered orally for 8 weeks during the assigned treatment period. In this two-period crossover study, the two treatment periods are separated by a 4-week washout period.

Sponsors & Collaborators

  • Mackay Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-09-30
Completion
2026-10-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07537816 on ClinicalTrials.gov