Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Desidustat: 100–150 mg orally three times a week, dose-titrated as per protocol for 24 weeks.
Control Intervention1: Erythropoietin alfa (rHuEPO): subcutaneous injection 50 IU/kg three
Sponsors
Government Medical College GMC Jammu India
Eligibility
Inclusion criteria
Inclusion criteria: Adults more than 18 years with CKD stages 3–5 (including maintenance dialysis) and anaemia (Hb less than 10 g/dL), who have provided informed consent.
Exclusion criteria
Exclusion criteria: Active bleeding, uncontrolled hypertension, malignancy, pregnancy or lactation, recent ESA use less than 8 weeks, severe hepatic impairment, known hypersensitivity to study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in haemoglobin (g/dL) from baseline to the evaluation period (Weeks 16–24).Timepoint: Weeks 16–24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion with Hb 10–12 g/dL by Week 24 2. Time to first target Hb 10–12 g/dL 3. Change in ferritin, TSAT, lipid profile, potassium 4. Incidence of adverse events (hyperkalaemia, hypertension, vascular access thrombosis, retinopathy). Timepoint: Weeks 16–24 | — |
Countries
India
Contacts
Public ContactMohit Goyal
Government Medical College, Jammu
Outcome results
None listed