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COMPLETEDPHASE3

Desidustat in the Treatment of Anemia in CKD on Dialysis Patients

A Phase 3, Multicenter, Open-label, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Epoetin Alfa Injection for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) on Dialysis (DREAM-D)

NCT04215120•Zydus Lifesciences Limited

View on ClinicalTrials.gov

Summary

A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of anemia in patients with CKD on dialysis. (DREAM-D)

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Ability to understand and give informed consent for participation. 2. Hemoglobin values during the screening period must be 8-11 g/dL (both inclusive).
•3\.
•1. Patients will be considered not treated with erythropoietin analogue (Epoetin and Darbepoeitin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera® for at least 8 weeks prior to screening visit. OR
•2. Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment (≤30% of dose change).
•4\. Patients on hemodialysis (≥2 times in a week) for at least 12 weeks prior to screening visit and have access consisting of an arteriovenous fistula, AV graft, or catheter (permanent/temporary).
•5\. Patients with no planned change in dialysis modality and with no planned renal transplant during study period.
•6\. Left ventricular ejection fraction ≥40% by echocardiogram prior to randomization.
•7\. No iron, folate or Vitamin B12 deficiency.
•8\. Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit.

Exclusion Criteria

•1. Red blood cell transfusion within 8 weeks prior to participating in the study.
•2. History of previous or concurrent cancer.
•3. Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
•4. Active infection at initiation of study.
•5. History of renal transplant.
•6. Uncontrolled hypertension (defined as SBP \>180 mmHg or DBP \>100 mmHg) at screening visit (before dialysis).
•7. Patient on high rhEPO dose at screening visit. \[High dose defined as an epoetin dose of ≥450 IU/kg/week intravenous or ≥ 300 IU/kg/week subcutaneous or darbepoetin dose of ≥1.5 µg/kg/week subcutaneous\].
•8. Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.
•9. Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
•10. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
+21 more criteria

Locations (7)

Karnavati Hospital Pvt.Ltd

Ahmedabad, Gujarat, India

Shalby Hospital,

Ahmedabad, Gujarat, India

DHS Multispecialty Hospital

Ahmedabad, Gujarat, India

Chopda Medicare & Research Centre Pvt. Ltd

Nashik, Maharashtra, India

Aditya Birla Memorial Hospital

Pune, Maharashtra, India

Eternal Hospital

Jaipur, Rajasthan, India

Star Hospital

Hyderabad, Telangana, India

Key Dates

Start Date

January 4, 2020

Primary Completion Date

September 2, 2021

Completion Date

September 2, 2021

Last Updated

November 24, 2021

Enrollment

392

ACTUAL participants

Conditions

Chronic Kidney Disease Stage 5 on Dialysis

Interventions

Desidustat Oral Tablet

DRUG

Epoetin Alfa

DRUG

Vaccination Against COVID-19 in Chronic Kidney Disease

NCT04743947

Chronic Kidney Disease Stage 5 on DialysisChronic Kidney Disease Stage 5 With Transplant+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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