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)

Zydus Lifesciences Limited7 sites in 1 country392 target enrollmentJanuary 4, 2020

ConditionsChronic Kidney Disease Stage 5 on Dialysis

InterventionsDesidustat Oral Tablet Epoetin Alfa

DrugsDesidustat Oral Tablet Epoetin Alfa

Overview

Phase: Phase 3
Intervention: Desidustat Oral Tablet
Conditions: Chronic Kidney Disease Stage 5 on Dialysis
Sponsor: Zydus Lifesciences Limited
Enrollment: 392
Locations: 7
Primary Endpoint: Hemoglobin level
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

January 4, 2020

End Date

September 2, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zydus Lifesciences Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand and give informed consent for participation.
•Hemoglobin values during the screening period must be 8-11 g/dL (both inclusive).
•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
•Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment (≤30% of dose change).
•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).
•Patients with no planned change in dialysis modality and with no planned renal transplant during study period.
•Left ventricular ejection fraction ≥40% by echocardiogram prior to randomization.
•No iron, folate or Vitamin B12 deficiency.
•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

•Red blood cell transfusion within 8 weeks prior to participating in the study.
•History of previous or concurrent cancer.
•Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
•Active infection at initiation of study.
•History of renal transplant.
•Uncontrolled hypertension (defined as SBP \>180 mmHg or DBP \>100 mmHg) at screening visit (before dialysis).
•Patient on high rhEPO dose at screening visit. \[High dose defined as an epoetin dose of ≥450 IU/kg/week intravenous or ≥ 300 IU/kg/week subcutaneous or darbepoetin dose of ≥1.5 µg/kg/week subcutaneous\].
•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.
•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.
•History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.