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Completed Phase 3 Interventional Results available

Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

ClinicalTrials.gov ID: NCT04313153

Public ClinicalTrials.gov record NCT04313153. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 4:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (ESA) therapy.

Study identification

NCT ID
NCT04313153
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Akebia Therapeutics
Industry
Enrollment
319 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 27, 2020 (Actual)
Primary completion
Nov 26, 2021 (Actual)
Completion
Jun 22, 2022 (Actual)
Last update posted
May 22, 2025

2020 – 2022

United States locations

U.S. sites
39
U.S. states
16
U.S. cities
34
Facility City State ZIP Site status
Research Site Chula Vista California 91910 —
Research Site Granada Hills California 91344 —
Research Site Los Angeles California 90022 —
Research Site Lynwood California 90262 —
Research Site Northridge California 91324 —
Research Site San Dimas California 91773 —
Research Site Whittier California 90603 —
Research Site Denver Colorado 80230 —
Research Site Middlebury Connecticut 06762 —
Research Site Coral Gables Florida 33134 —
Research Site Tampa Florida 33614 —
Research Site Winter Park Florida 32789 —
Research Site Pontiac Michigan 48341 —
Research Site Roseville Michigan 48066 —
Research Site Minneapolis Minnesota 55404 —
Research Site Brookhaven Mississippi 39601 —
Research Site Tupelo Mississippi 38801 —
Research Site Kansas City Missouri 64111 —
Research Site St Louis Missouri 63136 —
Research Site Las Vegas Nevada 89128 —
Research Site Albuquerque New Mexico 87109 —
Research Site Durham North Carolina 27704 —
Research Site Kinston North Carolina 28504 —
Research Site New Bern North Carolina 28562 —
Research Site Bethlehem Pennsylvania 18017 —
Research Site Orangeburg South Carolina 29118 —
Research Site Chattanooga Tennessee 37404 —
Research Site Knoxville Tennessee 37920 —
Research Site Knoxville Tennessee 37923 —
Research Site Austin Texas 78751 —
Research Site Austin Texas 78758 —
Research Site El Paso Texas 79902 —
Research Site Houston Texas 77004 —
Research Site Houston Texas 77099 —
Research Site McAllen Texas 78503 —
Research Site San Antonio Texas 78204 —
Research Site San Antonio Texas 78212 —
Research Site San Antonio Texas 78229 —
Research Site Hampton Virginia 23666 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04313153, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 22, 2025 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04313153 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →