An Open-label, Randomised, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Erythropoietin stimulating agent (ESA) for the Treatment of Anemia in Patients with Chronic Kidney Disease (CKD) on Peritoneal Dialysis

Study TitleAn Open-label, Randomised, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Erythropoietin Stimulating Agent (ESA) for the Treatment of Anemia in Patients with Chronic Kidney Disease (CKD) on Peritoneal Dialysis.

Study Details

• Type: Multi-center, Open-label, Randomised, Active-controlled, Prospective Study
• Drugs: Desidustat and ESA
• Site: Department of Nephrology, Army Hospital Research and Referral, New Delhi
• Investigator: Dr. Indranil Ghosh
• Duration: 24 Weeks
• Indication: Anemia of CKD
• Date of Protocol: 05-07-2024
• Patient Population: Patients with anemia in CKD on Peritoneal dialysis
• Number of Subjects: 90 (45 per arm)

Objectives

• Primary Objective: Assess the efficacy of Desidustat Tablet versus ESA based on changes in hemoglobin (Hb) levels over 24 weeks.
• Secondary Objectives: Evaluate the number of Hb responders, changes in serum hepcidin and HS-CRP levels, quality of life (SF-36), and treatment-emergent adverse drug reactions.

Inclusion Criteria

• Age ≥ 14 years
• Clinical diagnosis of anemia due to CKD with Hb < 11.0 g/dL
• No folate or Vitamin B12 deficiency
• On Peritoneal Dialysis for at least 12 weeks

Exclusion Criteria

• Recent red blood cell transfusion
• Uncontrolled diabetes or hypertension
• History of cancer, severe allergies, or chronic inflammatory diseases
• Active Hepatitis B/C or HIV infection
• Recent major or minor surgery
• Pregnant or breastfeeding women

Methodology

• Design: Multi-center, Open-label, Active-controlled Prospective study
• Randomisation: 1:1 ratio into Desidustat or ESA arms
• Visits: Screening (Week -4), Randomisation (Week 0), Follow-ups (Weeks 4, 8, 16, 24)
• Assessments: Vital signs, physical exams, safety and efficacy assessments, serum Hb, hepcidin, K+ levels, iron profile, AE collection, medication compliance, quality of life questionnaire

Treatment

• Desidustat Arm: 100mg orally thrice weekly
• ESA Arm: Darbapoietin or Inj CERA with dose adjustments based on current ESA dose

This study aims to demonstrate the noninferiority of Desidustat compared to ESA in treating anemia in CKD patients on Peritoneal dialysis