CTRI/2019/06/019635.

Study name	Desidustat in the treatment of anaemia in chronic kidney disease (CKD)
Methods	Study design: parallel RCT Expected duration of follow‐up: 24 weeks
Participants	General information Setting: multicentre Country: international Inclusion criteria: current clinical diagnosis of anaemia due to CKD, baseline Hb concentrations must be 7.0 to 10.0 g/dL (both inclusive) before the enrolment; 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 eGFR using the CKD Epidemiology Collaboration (CKD‐EPI) formula; aged 18 to 80 years; body weight > 40 kg; not on dialysis and not expected to start dialysis during the study period; not be treated with ESA therapy within 6 weeks prior to enrolment; eGFR < 10 mL/min/1.73 m², serum ferritin <100 ng/mL and/or TSAT > 20%, 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: prior chronic HD or chronic PD treatment; IV iron within 14 days prior to enrolment; prior exposure of RhuEPO analogues less than 4 weeks; RBC transfusion within 8 weeks prior to enrolment; history of previous or concurrent cancer; serologic status reflecting active hepatitis B or C infection or HIV infection; active infection prior to enrolment; history of kidney 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 GI 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 haemolytic anaemia, ITP or thalassaemia Target Hb: not reported CKD stage: 588 patients with CKD stages 3, 4, or 5
Interventions	Treatment group Desidustat (oral): 100 mg 3 times/week Control group Darbepoetin (IV or SC): 0.75 µg/kg once every 2 weeks Co‐interventions Not reported
Outcomes	Primary outcome Change in Hb levels at week 16 and 24 Secondary outcomes Percentage of time spent in target Hb range up to week 24 Change in hepcidin Change in QoL by SF‐36 at week 12 and 24
Starting date	June 2019
Contact information	kevinkumar.kansagra@zyduscadila.com
Notes	Study completion status: approved Funding: Cadila Healthcare Ltd