Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis Patients
Phase 4 – monitoring after market approval
Conditions:
Renal Anemia
Sponsor: Mackay Memorial Hospital
trial.available_in:
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Overview
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
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