NCT03303066 is a Phase 2, PHASE3 clinical trial of FG-4592 in Anemia, sponsored by Kyntra Bio.

Who is sponsoring NCT03303066?

NCT03303066 is sponsored by Kyntra Bio.

What drugs are being tested in NCT03303066?

Interventions in NCT03303066: FG-4592, Placebo.

What condition does NCT03303066 study?

NCT03303066 studies Anemia, Myelodysplastic Syndrome.

Is NCT03303066 still recruiting?

NCT03303066 is currently completed. Last updated 3 May 2023.

Last reviewed 2023-05-03 · How we verify

NCT03303066

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

Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)

Completed Phase 2, PHASE3 Last updated 3 May 2023

What this trial tests

Phase 2, PHASE3 trial testing FG-4592 in Anemia in 43 participants. Completed in 8 February 2023.

Timeline

6 June 2018

Primary endpoint
11 January 2023

8 February 2023

Quick facts

Lead sponsor	Kyntra Bio
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	43
Start date	6 June 2018
Primary completion	11 January 2023
Estimated completion	8 February 2023
Sites	38 locations across China

Drugs / interventions tested

FG-4592 — full drug profile →
Placebo

Conditions studied

Anemia — all drugs for Anemia →
Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →

Sponsor

Kyntra Bio — full company profile →

Who can join

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

Sponsor's own description

The objective of this study to evaluate the efficacy FG-4592 for the treatment of anemia in Chinese participants with lower risk MDS.

Publications & conference data

8 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
Hypoxia-Inducible Factor Activators in Renal Anemia: Current Clinical Experience.
Sanghani NS, Haase VH. · · 2019 · cited 139× · PMID 31477256 · DOI 10.1053/j.ackd.2019.04.004
Hypoxia-inducible factor-prolyl hydroxylase inhibitors in the treatment of anemia of chronic kidney disease.
Haase VH. · · 2021 · cited 115× · PMID 33777492 · DOI 10.1016/j.kisu.2020.12.002
Current challenges and unmet medical needs in myelodysplastic syndromes.
Platzbecker U, Kubasch AS, Homer-Bouthiette C, Prebet T. · · 2021 · cited 67× · PMID 34045662 · DOI 10.1038/s41375-021-01265-7
Genome-Wide Interrogation of Human Cancers Identifies EGLN1 Dependency in Clear Cell Ovarian Cancers.
Price C, Gill S, Ho ZV, Davidson SM, et al · · 2019 · cited 44× · PMID 30898838 · DOI 10.1158/0008-5472.can-18-2674
Treatment of Anemia in Transfusion-Dependent and Non-Transfusion-Dependent Lower-Risk MDS: Current and Emerging Strategies.
Germing U, Oliva EN, Hiwase D, Almeida A. · · 2019 · cited 36× · PMID 31976486 · DOI 10.1097/hs9.0000000000000314
Clinical and Molecular Insights in Erythropoiesis Regulation of Signal Transduction Pathways in Myelodysplastic Syndromes and β-Thalassemia.
Parisi S, Finelli C, Fazio A, De Stefano A, et al · · 2021 · cited 25× · PMID 33467674 · DOI 10.3390/ijms22020827
Whether Prolyl Hydroxylase Blocker-Roxadustat-In the Treatment of Anemia in Patients with Chronic Kidney Disease Is the Future?
Grzeszczak W, Szczyra D, Śnit M. · · 2021 · cited 5× · PMID 33567688 · DOI 10.3390/ijerph18041612

Verify or expand the search:

Other recruiting trials for Anemia

Currently open trials in the same condition.

NCT07422480 — A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myel · Phase 3 · recruiting
NCT06968936 — Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy · NA · recruiting
NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML · NA · recruiting
NCT07315295 — Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya · NA · recruiting
NCT07400796 — Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia · recruiting

Other Kyntra Bio trials

Trials by the same sponsor.

NCT06842498 — A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) · Phase 2 · recruiting
NCT04621331 — Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD · Phase 3 · withdrawn
NCT05301517 — A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemothe · Phase 3 · completed
NCT04632940 — Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD · Phase 3 · terminated
NCT04419558 — Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) · Phase 3 · terminated

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 NCT03303066 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Kyntra Bio
Last refreshed: 3 May 2023

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/NCT03303066.

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