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Completed Phase 3 Interventional Results available

Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants

ClinicalTrials.gov ID: NCT04410198

Public ClinicalTrials.gov record NCT04410198. 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 Jul 22, 2026, 9:39 PM EDT

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

Official title

A Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From a Continuous Erythropoietin Receptor Activator (CERA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients - DENALI Study

Study identification

NCT ID
NCT04410198
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kyntra Bio
Industry
Enrollment
203 participants

Conditions and interventions

Interventions

  • Roxadustat Drug

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 25, 2020
Primary completion
Jun 29, 2021
Completion
Oct 10, 2021
Last update posted
Sep 12, 2022

2020 – 2021

United States locations

U.S. sites
9
U.S. states
9
U.S. cities
9
Facility City State ZIP Site status
Investigational Site Englewood Colorado 80110
Investigational Site Caldwell Idaho 83642
Investigational Site Baton Rouge Louisiana 70808
Investigational Site Kalamazoo Michigan 49009
Investigational Site Tupelo Mississippi 38801
Investigational Site Saint Ann Missouri 63074
Investigational Site Las Vegas Nevada 89106
Investigational Site Sugar Land Texas 77479
Investigational Site St. George Utah 84790

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04410198, 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 Sep 12, 2022 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04410198 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →