Trials / Terminated
TerminatedNCT03263091
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 184 (actual)
- Sponsor
- Kyntra Bio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.
Detailed description
This study includes an Open-Label Lead in, a Double-Blind component, and an Open-Label High Erythropoietin component. There is a screening period of up to 42 days followed by a treatment period of 52 weeks and a 4-week end of treatment assessment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roxadustat | Oral tablets |
| DRUG | Placebo | Oral tablets |
Timeline
- Start date
- 2018-01-29
- Primary completion
- 2023-03-09
- Completion
- 2023-06-20
- First posted
- 2017-08-28
- Last updated
- 2024-08-01
- Results posted
- 2024-08-01
Locations
124 sites across 16 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, India, Israel, Italy, Poland, Russia, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03263091. Inclusion in this directory is not an endorsement.