NCT07537816

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
5mo left

Started Apr 2026

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

April 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 12, 2026

Last Update Submit

April 19, 2026

Conditions

Renal Anemia

Outcome Measures

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.

    Baseline and end of each 8-week treatment period (up to 5 months).

Secondary Outcomes (9)

  • Change in SF-36 Physical Component Summary score

    Baseline and end of each 8-week treatment period (up to 5 months).

  • Change in SF-36 Mental Component Summary score

    Baseline and end of each 8-week treatment period (up to 5 months).

  • Change in C-reactive protein

    Baseline and monthly during the study period, up to 5 months.

  • Change in erythrocyte sedimentation rate

    Baseline and monthly during the study period, up to 5 months.

  • Change in interleukin-6

    Baseline and monthly during the study period, up to 5 months.

  • +4 more secondary outcomes

Study Arms (2)

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.

Drug: Vadadustat

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.

Drug: Vadadustat

Interventions

VadadustatDRUG

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.

Also known as: Darbepoetin alfa
AB sequence: Vadadustat add-on followed by darbepoetin alfa aloneBA sequence: Darbepoetin alfa alone followed by vadadustat add-on

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

vadadustatDarbepoetin alfa

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2026

First Posted

April 17, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04