A Phase 3, Multicenter, Multi-country, Open-label, Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Who Are Not on Dialysis

Zydus Lifesciences Limited30 sites in 1 country588 target enrollmentJuly 20, 2019

ConditionsChronic Kidney Disease Stage 3 Anemia Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 5

InterventionsDarbepoetin Alfa Desidustat Oral Tablet

DrugsDesidustat Oral Tablet Darbepoetin Alfa

Overview

Phase: Phase 3
Intervention: Darbepoetin Alfa
Conditions: Chronic Kidney Disease Stage 3
Sponsor: Zydus Lifesciences Limited
Enrollment: 588
Locations: 30
Primary Endpoint: Hemoglobin level
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks.

Registry

clinicaltrials.gov

Start Date

July 20, 2019

End Date

August 25, 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

•Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-10.0 g/dL (both inclusive) before the enrollment.
•Ability to understand and give informed consent for participation.
•Male or female patients diagnosed with CKD (stage III to V, not receiving dialysis) defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
•Male or female, 18 to 80 years of age.
•Body weight \> 40 kg.
•Subjects not on dialysis and not expected to start dialysis during the study period.
•Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy within 6 weeks prior to enrollment.
•Estimated GFR ≥10 mL/min/1.73 m
•Serum ferritin ≥100 ng/mL and/or Transferrin Saturation \>20%.
•No iron, folate or Vitamin B12 deficiency.

Exclusion Criteria

•Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
•Intravenous iron within 14 days prior to enrollment.
•Prior exposure of rhEPO analogues less than 04 weeks.
•Red blood cell transfusion within 8 weeks prior to enrollment.
•History of previous or concurrent cancer.
•Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
•Active infection prior to enrollment.
•History of renal transplant.
•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; mal-absorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.