A study to assess the effect of desidustat in comparison to erythropoietin in patients of anaemia with kidney disease
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2023/05/052681
- Lead Sponsor
- Dr Hiramani Rabha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Patient of either sex and aged >= 18years
2)Patients with anaemia (Hb <= 9g/dl) with Chronic Kidney Disease stage III-V not on hemodialysis or peritoneal dialysis , with adequate iron stores (ferritin, TSAT)
3)Patients willing to give informed consent
1)Patients with hyperkalemia (documented either in biochemical tests or ECG)
2)History of haematological disorders like uncontrolled autoimmune hemolytic anaemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia
3)Red blood cell transfusion within 6 weeks prior to participating in the study
4)History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
5)History of allergic reactions attributed to compounds of similar chemical or biologic composition of Desidustat or erythropoietin
6)Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
7)Current infectious disease like active hepatitis, active tuberculosis etc.
8)Pregnant and breastfeeding women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method