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NCT Number: NCT07537816

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

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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Key information

Conditions

Renal Anemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Darbepoetin alfa

Primary outcomes

  1. Change in Hemoglobin

    Time frame: 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 outcomes

  1. Change in SF-36 Physical Component Summary score

    Time frame: 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.

  2. Change in SF-36 Mental Component Summary score

    Time frame: 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.

  3. Change in C-reactive protein

    Time frame: 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.

  4. Change in erythrocyte sedimentation rate

    Time frame: 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.

  5. Change in interleukin-6

    Time frame: 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.

  6. Change in serum iron

    Time frame: 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.

  7. Change in total iron-binding capacity

    Time frame: 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.

  8. Change in ferritin

    Time frame: 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.

  9. Change in transferrin saturation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

A Prospective Interventional Study Evaluating the Effects of Vadadustat on Anemia, Quality of Life, and Inflammatory Response in Dialysis Patients and Exploring Predictors of Treatment Response

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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