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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Vadadustat
DrugVadadustat administered orally for 8 weeks during the assigned treatment period. In this two-period crossover study, the two treatment periods are separated by a 4-week washout period.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: AB sequence: Vadadustat add-on followed by darbepoetin alfa aloneOther 1 intervention
Group B: BA sequence: Darbepoetin alfa alone followed by vadadustat add-onOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Hemoglobin
Within-participant change in hemoglobin during add-on vadadustat treatment compared with background darbepoetin alfa alone in this two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis.
Time frame
Baseline and end of each 8-week treatment period (up to 5 months).Secondary outcomes
1
Change in SF-36 Physical Component Summary score
Change in health-related quality of life as assessed by the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score during add-on vadadustat treatment compared with background darbepoetin alfa alone in this two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. Higher scores indicate better physical health status.
Time frame
Baseline and end of each 8-week treatment period (up to 5 months).2
Change in SF-36 Mental Component Summary score
Change in health-related quality of life as assessed by the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) score during add-on vadadustat treatment compared with background darbepoetin alfa alone in this two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. Higher scores indicate better mental health status.
Time frame
Baseline and end of each 8-week treatment period (up to 5 months).3
Change in C-reactive protein
Change in serum C-reactive protein during add-on vadadustat treatment compared with background darbepoetin alfa alone.
Time frame
Baseline and monthly during the study period, up to 5 months.4
Change in erythrocyte sedimentation rate
Change in erythrocyte sedimentation rate during add-on vadadustat treatment compared with background darbepoetin alfa alone.
Time frame
Baseline and monthly during the study period, up to 5 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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