NCT07537816

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

A Prospective Interventional Study Evaluating the Effects of Vadadustat on Anemia, Quality of Life, and Inflammatory Response in Dialysis Patients and Exploring Predictors of Treatment Response

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-09-30
• Completion: 2026-10-15
• First posted: 2026-04-17
• Last updated: 2026-04-17