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

ConditionRenal Anemia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMackay Memorial Hospital

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

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators