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

April 19, 2026 updated by: Mackay Memorial Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AB sequence: Vadadustat add-on followed by darbepoetin alfa alone
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.
Drug: Vadadustat
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
Other: BA sequence: Darbepoetin alfa alone followed by vadadustat add-on
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.
Drug: Vadadustat
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and end of each 8-week treatment period (up to 5 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and end of each 8-week treatment period (up to 5 months).
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.
Baseline and end of each 8-week treatment period (up to 5 months).
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.
Baseline and monthly during the study period, up to 5 months.
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.
Baseline and monthly during the study period, up to 5 months.
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.
Baseline and monthly during the study period, up to 5 months.
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.
Baseline and monthly during the study period, up to 5 months.
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.
Baseline and monthly during the study period, up to 5 months.
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.
Baseline and monthly during the study period, up to 5 months.
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.
Baseline and monthly during the study period, up to 5 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

April 12, 2026

First Submitted That Met QC Criteria

April 12, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24MMHIS374e

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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