About this trial
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.
Eligibility criteria
Qualifiers
Age 18 years or older
Receiving maintenance peritoneal dialysis
Followed at the outpatient clinics of MacKay Memorial Hospital
Receiving background darbepoetin alfa therapy
Disqualifiers
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
Trial design
Treatments tested in this trial
- Vadadustat