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ACTIVE NOT RECRUITING
NCT06901505
PHASE3

To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis

Sponsor: Akebia Therapeutics

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.

Official title: A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

353

Start Date

2025-07-24

Completion Date

2026-08

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

Erythropoiesis-Stimulating Agent (ESA)

Administered by intra-venous (IV) infusion.

DRUG

Vadadustat

300mg, oral tablets

Locations (18)

DaVita Research Site

Montgomery, Alabama, United States

DaVita Research Site

Hartford, Connecticut, United States

DaVita Research Site

Middlebury, Connecticut, United States

DaVita Research Site

Columbus, Georgia, United States

DaVita Research Site #1

Minneapolis, Minnesota, United States

DaVita Research Site

Minneapolis, Minnesota, United States

DaVita Research Site

Henderson, Nevada, United States

DaVita Research Site

Las Vegas, Nevada, United States

DaVita Research Site #1

El Paso, Texas, United States

DaVita Research Site

El Paso, Texas, United States

DaVita Research Site #1

Houston, Texas, United States

DaVita Research Site

Houston, Texas, United States

DaVita Research Site #1

San Antonio, Texas, United States

DaVita Research Site #2

San Antonio, Texas, United States

DaVita Research Site

San Antonio, Texas, United States

DaVita Research Site

The Woodlands, Texas, United States

DaVita Research Site #1

Norfolk, Virginia, United States

DaVita Research Site

Norfolk, Virginia, United States