A Phase 3 interventional study of Roxadustat and Placebo in Myelodysplastic Syndromes, sponsored by Kyntra Bio. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Kyntra Bio · Phase 3, Interventional, and Treatment
The study is designed to determine the efficacy and safety of roxadustat for the treatment of anemia due to very low, low, or intermediate risk MDS in participants with high transfusion burden (HTB).
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
This study's planned enrollment of 201 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →Kyntra Bio is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive roxadustat, administered orally 3 times per week (TIW).
Drug: Roxadustat
Participants will receive placebo matching to roxadustat, administered orally TIW.
Drug: Placebo
Roxadustat will be administered per schedule specified in the arm description.
Also known as: FG-4592
Placebo matching to roxadustat will be administered per schedule specified in the arm description.
Percentage of Participants With Red Blood Cell-transfusion Independence (RBC-TI) Over Any Consecutive 56-day Period
Time frame: Week 1 through Week 24
Percentage of Participants With RBC-TI Over Any Consecutive 84-day Period
Time frame: Week 1 through Week 48 or end of treatment (EOT; up to 5 years)
Percentage of Participants With RBC-TI Over Any Consecutive 112-day Period
Time frame: Week 1 through Week 48 or EOT (up to 5 years)
Percentage of Participants With ≥50% Reduction in Rate of Total Red Blood Cell (RBC) Units Transfused During a 16-week Period
Time frame: Week 1 through Week 48 or EOT (up to 5 years)
Percentage of Participants With RBC-TI Over Any Consecutive 168-day Period
Time frame: Week 1 through Week 48 or EOT (up to 5 years)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2027; primary completion for Sep 2030, 41 months later.
Of 26 industry-sponsored phase 3 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 52. This study's planned 41 months is close to that.
Counting every sponsor, half of 45 studies reached it within 50 months; a quarter within 38 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Roxadustat