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Not yet recruiting Phase 4 NCT07537816

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: БГ
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
Interventions
Vadadustat
DRUG
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.04.2026
Completion date
15.10.2026
Registry ID
NCT07537816
Source
clinicaltrials.gov
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