Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jun 2018

Longer than P75 for phase_2

Geographic Reach

1 country

38 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.7 years study duration

First Submitted

Initial submission to the registry

October 2, 2017

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed

8 months until next milestone

Study Start

First participant enrolled

June 6, 2018

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2023

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2023

Completed

Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

4.6 years

First QC Date

October 2, 2017

Last Update Submit

May 1, 2023

Conditions

Anemia Myelodysplastic Syndrome

Keywords

Myelodysplastic SyndromesAnemiaHemoglobin (Hb)Low Risk Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With a Hemoglobin (Hb) Response to FG-4592 Without Transfusion
Hemoglobin response to FG-4592 is defined as an increase in mean Hb of ≥1.0 grams (g)/deciliter (dL) from baseline within any 8-week period during the study without transfusion.
26 weeks

Secondary Outcomes (6)

Number of Participants With Hb Increase ≥1.0 g/dL From Baseline
26 weeks
Time to First Hb Response
26 weeks
Change From Baseline in Mean Hb in Weeks 25 to 27
Baseline, Weeks 25 to 27
Percentage of Participants With Mean Hb ≥10.0 g/dL Within Any 8-week Period During the Study Without Transfusion
26 weeks
Number of Participants that Require Transfusions or Hb <6 g/dL up to Week 27
Up to Week 27
+1 more secondary outcomes

Study Arms (3)

Phase 2 Part: FG-4592

EXPERIMENTAL

Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally 3 times a week (TIW) for up to 26 weeks; dose adjustments to Hb levels are allowed during the study.

Drug: FG-4592

Phase 3 Part: FG-4592

EXPERIMENTAL

Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally TIW for up to 26 weeks; dose adjustments to Hb levels are allowed during the study.

Drug: FG-4592

Phase 3 Part: Placebo

PLACEBO COMPARATOR

Placebo (matching to FG-4592) administered orally TIW for up to 26 weeks.

Drug: Placebo

Interventions

FG-4592DRUG

Oral

Also known as: Roxadustat, AZD9941

Phase 2 Part: FG-4592Phase 3 Part: FG-4592

PlaceboDRUG

Oral

Phase 3 Part: Placebo

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of primary MDS classified as very low, low or intermediate risk with \<5% blasts (documented within 12 weeks prior to Day 1)
Screening Hb \<10 g/dL and ≥6g/dL
Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1
Erythropoiesis-stimulating agent (ESA)-naïve (not within 30 days of Day 1)
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

You may not qualify if:

Diagnosis of secondary MDS
Significant myelofibrosis (\>2+fibrosis)
Prior therapy with azacitidine, decitabine, antithymocyte globulin, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to Day 1
Baseline erythropoietin level of \>400 units (U)/liter (L)
Clinically significant anemia due to non-MDS etiologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Kyntra Biolead
AstraZenecacollaborator

Study Sites (38)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Anhui Provincial Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

China-Japan Friendship Hospital