NCT04454879

Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

Completed Phase 4 Last updated 26 November 2021

What this trial tests

Phase 4 trial testing Roxadustat in Renal Anemia in 100 participants. Completed in 3 August 2021.

Timeline

1 July 2020

Primary endpoint
3 April 2021

3 August 2021

Quick facts

Lead sponsor	Peking University First Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 July 2020
Primary completion	3 April 2021
Estimated completion	3 August 2021
Sites	1 location across China

Drugs / interventions tested

• Roxadustat (ROXADUSTAT) — full drug profile →

Conditions studied

• Renal Anemia — all drugs for Renal Anemia →

Sponsor

Peking University First Hospital

Who can join

Adults 18 to 80, any sex, with Renal Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A multi-center, randomized, controlled study to evaluate the effect of different doses of roxadustate on hemoglobin target-met in peritoneal dialysis patients

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized Study on the Efficacy of Standard Versus Low Roxadustat Dose for Anemia in Patients on Peritoneal Dialysis.
   Yang Z, Ma T, Xu X, Fu G, et al · · 2022 · cited 8× · PMID 35257058 · DOI 10.1016/j.ekir.2021.12.025
2. A critical review of Roxadustat formulations, solid state studies, and analytical methodology.
   Mahajan R, Samanthula G, Srivastava S, Asthana A. · · 2023 · cited 3× · PMID 37346363 · DOI 10.1016/j.heliyon.2023.e16595