A study to compare desidustat and darbepoetin alfa for treatment of anaemia in patients with chronic kidney disease not on dialysis

An open label randomised controlled trial to study the efficacy of desidustat versus darbepoetin alfa with hepcidin levels in non dialysis chronic kidney disease anemia - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106748

Enrollment

Registered

2026-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Desidustat: Desidustat administered orally at a dose of 100 mg weekly thrice. Dose titration will be done based on haemoglobin response as per protocol. Duration of the treatment will b

Eligibility

Inclusion criteria

Inclusion criteria: All 18 years or above patients with chronic kidney disease stage 3 to 5 not on dialysis. Hemoglobin between 7 to 11 grams per decilitre. Stable renal function. Willing to give informed consent.

Exclusion criteria

Exclusion criteria: Patients on dialysis. Active infections. Recent blood transfusion in past 8 weeks. Known malignancy. Pregnancy and lactation. History of renal transplant. Patients with ADPKD. White blood cells count less than 3000 per microlitre and platelets count less than 100000 per microlitre. Uncontrolled hypertension. Known hypersensitivity to study drugs

Design outcomes

Primary

Measure	Time frame
Change in hemoglobin levels from baseline and time to achieve target haemoglobin rangeTimepoint: At 24 weeks	—

Secondary

Measure	Time frame
Change in hepcidin levels from baselineTimepoint: At baseline and 24 weeks;Change in low density lipoprotein levels from baselineTimepoint: At baseline and 24 weeks;Incidence of adverse eventsTimepoint: Throughout study duration;Progression of chronic kidney diseaseTimepoint: at 24 weeks	—

Countries

India

Contacts

Public ContactDr Ritesh R Vernekar

Jawaharlal Nehru Medical College and Dr Prabhakar Kore Hospital & Medical Research Centre

riteshvernekar@gmail.com9449061633

Outcome results

None listed

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