NCT04925011 is a Phase 3 clinical trial of Roxadustat in Anemia Associated With Chronic Kidney Disease, sponsored by Mao Jianhua.

Who is sponsoring NCT04925011?

NCT04925011 is sponsored by Mao Jianhua.

What drugs are being tested in NCT04925011?

Interventions in NCT04925011: Roxadustat.

What condition does NCT04925011 study?

NCT04925011 studies Anemia Associated With Chronic Kidney Disease.

Is NCT04925011 still recruiting?

NCT04925011 is currently status unknown. Last updated 9 August 2021.

Last reviewed 2021-08-09 · How we verify

NCT04925011

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD

Status unknown Phase 3 Last updated 9 August 2021

What this trial tests

Phase 3 trial testing Roxadustat in Anemia Associated With Chronic Kidney Disease in 30 participants. Status unknown.

Timeline

1 September 2021

Primary endpoint
30 June 2022

30 December 2022

Quick facts

Lead sponsor	Mao Jianhua
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 September 2021
Primary completion	30 June 2022
Estimated completion	30 December 2022
Sites	1 location across China

Drugs / interventions tested

Roxadustat (ROXADUSTAT) — full drug profile →

Conditions studied

Anemia Associated With Chronic Kidney Disease — all drugs for Anemia Associated With Chronic Kidney Disease →

Sponsor

Mao Jianhua — full company profile →

Who can join

Adults 2 to 18, any sex, with Anemia Associated With Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This open-labeled, one-center study is designed to evaluate the efficacy and safety of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5 who are receiving dialysis or not. The study will enroll patients between the ages of 2 to \<18 years. Approximately 30 patients will be enrolled.

Publications & conference data

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

Targeting hypoxia-inducible factors: therapeutic opportunities and challenges.
Yuan X, Ruan W, Bobrow B, Carmeliet P, et al · · 2024 · cited 144× · PMID 38123660 · DOI 10.1038/s41573-023-00848-6
Chronic kidney disease in children: an update.
Cirillo L, De Chiara L, Innocenti S, Errichiello C, et al · · 2023 · cited 25× · PMID 37779846 · DOI 10.1093/ckj/sfad097
Global, regional and country-specific burden of chronic kidney disease due to type 1 diabetes mellitus: A systematic analysis of the 2021 global disease burden study.
Sun J, Hu W, Ye S, Xu M, et al · · 2025 · cited 7× · PMID 40116333 · DOI 10.1111/dom.16358
Compassionate use of roxadustat for treatment of refractory renal anemia in an infant.
Yang Y, Chen Y, Yang Y, Bai H, et al · · 2024 · cited 1× · PMID 38086983 · DOI 10.1007/s00467-023-06240-1
Roxadustat for ESA-Hyporesponsive Renal Anemia in a 13-Year-Old on Hemodialysis: Case Report and Mini-Review.
Zhang M, Guo Y, Zhu Y, Yang J. · · 2025 · PMID 41018998 · DOI 10.1002/ccr3.70985

Verify or expand the search:

Other trials of Roxadustat

Trials testing the same drug.

NCT07268807 — Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease · not yet recruiting
NCT07162090 — Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients · Phase 4 · not yet recruiting
NCT05810311 — The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy · Phase 2 · not yet recruiting
NCT06903559 — Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients · Phase 1, PHASE2 · recruiting
NCT06917950 — Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients · Phase 1, PHASE2 · recruiting

Other Mao Jianhua trials

Trials by the same sponsor.

NCT07087314 — A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequen · Phase 2 · recruiting
NCT06789107 — Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus · Phase 1 · recruiting
NCT06079788 — Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospe · Phase 3 · recruiting
NCT03199508 — Clinical Values of Voiding Diary for Diagnosis and Treatment for Monosymptomatic Enuresis in Children · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04925011 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mao Jianhua
Last refreshed: 9 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04925011.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing