Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Desidustat: 100 mg will be given orally thrice a week for 6 months
Control Intervention1: Erythropoietin: 0.75ug/kg subcutaneously given once in 2 weeks for 6months
Sponsors
Dr Hiramani Rabha
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Raise in the Hb level over six months of interventionTimepoint: six months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Change in haematological biomarkers like Ferritin,TSAT, TIBC,Serum electrolytes, LFT 2)Change in anti-inflammatory biomarker IL-6, CRP 3)Assessment of quality of life by using CKD-AQ questionnaireTimepoint: six months | — |
Countries
India
Contacts
Public ContactDr Syed Shariq Naeem
Jawaharlal Nehru Medical College
Outcome results
None listed