To study the effect of drug Desidustat in patient with blood disorders

To study the safety and efficacy of oral Desidustat for treatment of anemia in patients with Lower risk Myelodysplastic syndrome [MDS] and Myeloproliferative neoplasms [MPN] - Not applicable

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093855

Enrollment

Registered

2025-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: Tab Desidustat: Tab Desidustat 100mg x 3 times a week x 6 months After 2 months if no response increase Tab Desidustat to 150mg x 3 times a week x 4 months Control Intervention1: Not ap

Eligibility

Inclusion criteria

Inclusion criteria: a)Very low, low, or intermediate-risk MDS based on IPSS-R score with less than 5% bone marrow blasts; baseline Hb of less than or equal to 9 g/dL; b)MPN with anemia; c)18 years and above and d)Low RBC transfusion burden, defined as 1?4 packed red blood cell (pRBC) units per 8-week period or 1 pRBC transfusion per 8-week period for 2 consecutive 8-week periods before randomization.

Exclusion criteria

Exclusion criteria: a)Higher ? risk MDS; Del 5q cytogenetic abnormality; or have anemia of a non-MDS etiology (e.g., iron deficiency). b)Children c)Patients who are unable to come for a visit atleast every 2 months in the initial 6 month period of the study.

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint will be the proportion of patients who were TI for more than or equal to 8 consecutive weeks during the first 28 treatment weeks.Timepoint: 2 months 6 months 12 months 18 months 24 months	—

Secondary

Measure	Time frame
(1) Study the proportion of patients who had above 50% reduction in the number of RBC transfusions over any 8 weeks compared with baseline, (2) Study the proportion of patients who were TI for more than 20 consecutive weeks. (3) Study the proportion of patients who develop Grade 3 or more toxicity (4) To explore whether HIFa expression in peripheral blood at baseline or other time points correlates with response. (5) Explore if EPO levels and iron related parameters predict response to therapy. Timepoint: 2 months 6 months 12 months 18 months 24 months	—

Measure

Time frame

(1) Study the proportion of patients who had above 50% reduction in the number of RBC transfusions over any 8 weeks compared with baseline, (2) Study the proportion of patients who were TI for more than 20 consecutive weeks. (3) Study the proportion of patients who develop Grade 3 or more toxicity (4) To explore whether HIFa expression in peripheral blood at baseline or other time points correlates with response. (5) Explore if EPO levels and iron related parameters predict response to therapy. Timepoint: 2 months 6 months 12 months 18 months 24 months

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Countries

India

Contacts

Public ContactArchita R

Christian Medical College Vellore Ranipet campus

archita.r@cmcvellore.ac.in04172224553

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026