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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB sequence: Vadadustat add-on followed by darbepoetin alfa alone | Other | Participants receive oral vadadustat in addition to background darbepoetin alfa during period 1 for 8 weeks, followed by background darbepoetin alfa alone during period 2 for 8 weeks. The two treatment periods are separated by a 4-week washout period. |
|
| BA sequence: Darbepoetin alfa alone followed by vadadustat add-on | Other | Participants receive background darbepoetin alfa alone during period 1 for 8 weeks, followed by oral vadadustat in addition to background darbepoetin alfa during period 2 for 8 weeks. The two treatment periods are separated by a 4-week washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vadadustat | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and end of each 8-week treatment period (up to 5 months). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C000624313 | vadadustat |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
| Baseline and end of each 8-week treatment period (up to 5 months). |
| 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. | Baseline and end of each 8-week treatment period (up to 5 months). |
| Change in C-reactive protein | Change in serum C-reactive protein during add-on vadadustat treatment compared with background darbepoetin alfa alone. | Baseline and monthly during the study period, up to 5 months. |
| Change in erythrocyte sedimentation rate | Change in erythrocyte sedimentation rate during add-on vadadustat treatment compared with background darbepoetin alfa alone. | Baseline and monthly during the study period, up to 5 months. |
| Change in interleukin-6 | Change in serum interleukin-6 during add-on vadadustat treatment compared with background darbepoetin alfa alone. | Baseline and monthly during the study period, up to 5 months. |
| Change in serum iron | Change in serum iron during add-on vadadustat treatment compared with background darbepoetin alfa alone. | Baseline and monthly during the study period, up to 5 months. |
| Change in total iron-binding capacity | Change in serum total iron-binding capacity during add-on vadadustat treatment compared with background darbepoetin alfa alone. | Baseline and monthly during the study period, up to 5 months. |
| Change in ferritin | Change in serum ferritin during add-on vadadustat treatment compared with background darbepoetin alfa alone. | Baseline and monthly during the study period, up to 5 months. |
| Change in transferrin saturation | Change in transferrin saturation during add-on vadadustat treatment compared with background darbepoetin alfa alone. | Baseline and monthly during the study period, up to 5 months. |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |