Renal Anemia
Conditions
Brief summary
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.
Interventions
DRUGVadadustat
Vadadustat 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.
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin | Baseline and end of each 8-week treatment period (up to 5 months). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SF-36 Physical Component Summary score | Baseline and end of each 8-week treatment period (up to 5 months). | 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. |
| Change in SF-36 Mental Component Summary score | Baseline and end of each 8-week treatment period (up to 5 months). | 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. |
| Change in C-reactive protein | Baseline and monthly during the study period, up to 5 months. | Change in serum C-reactive protein during add-on vadadustat treatment compared with background darbepoetin alfa alone. |
| Change in erythrocyte sedimentation rate | Baseline and monthly during the study period, up to 5 months. | Change in erythrocyte sedimentation rate during add-on vadadustat treatment compared with background darbepoetin alfa alone. |
| Change in interleukin-6 | Baseline and monthly during the study period, up to 5 months. | Change in serum interleukin-6 during add-on vadadustat treatment compared with background darbepoetin alfa alone. |
| Change in serum iron | Baseline and monthly during the study period, up to 5 months. | Change in serum iron during add-on vadadustat treatment compared with background darbepoetin alfa alone. |
| Change in total iron-binding capacity | Baseline and monthly during the study period, up to 5 months. | Change in serum total iron-binding capacity during add-on vadadustat treatment compared with background darbepoetin alfa alone. |
| Change in ferritin | Baseline and monthly during the study period, up to 5 months. | Change in serum ferritin during add-on vadadustat treatment compared with background darbepoetin alfa alone. |
| Change in transferrin saturation | Baseline and monthly during the study period, up to 5 months. | Change in transferrin saturation during add-on vadadustat treatment compared with background darbepoetin alfa alone. |
Outcome results
None listed