Desidustat in the treatment of anemia in Chronic Kidney Disease(CKD)
- Conditions
- Health Condition 1: D631- Anemia in chronic kidney disease
- Registration Number
- CTRI/2019/06/019635
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 531
1. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin
concentrations must be 7.0-10.0 g/dL (both inclusive) before the enrollment.
2. Ability to understand and give informed consent for participation.
3. 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.
4. Male or female, 18 to 80 years of age.
5. Body weight > 40 kg.
6. Subjects not on dialysis and not expected to start dialysis during the study period.
7. Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy
within 6 weeks prior to enrollment.
8. Estimated GFR >=10 mL/min/1.73 m2.
9. Serum ferritin >=100 ng/mL and/or TSAT >20%.
10. No iron, folate or Vitamin B12 deficiency.
11. Females of childbearing potential, must agree to use one of the approved
contraception methods, from screening until completion of the follow-up visit.
1. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
2. Intravenous iron within 14 days prior to enrollment.
3. Prior exposure of rhEPO analogues less than 04 weeks.
4. Red blood cell transfusion within 8 weeks prior to enrollment.
5. History of previous or concurrent cancer.
6. Serologic status reflecting active hepatitis B or C infection or
Human immunodeficiency virus (HIV) infection.
7. Active infection prior to enrollment.
8. History of renal transplant.
9. 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.
10. 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.
11. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method