drugset / Trial / NCT07537816
Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis Patients
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2026-04-15
- Primary completion
- 2026-09-30
- Completion
- 2026-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vadadustat | Small molecule | — | Oral |