Health Condition 1: N184- Chronic kidney disease, stage 4 (severe) Health Condition 2: N182- Chronic kidney disease, stage 2 (mild) Health Condition 3: N183- Chronic kidney disease, stage 3 (moderate)
Conditions
Interventions
Intervention1: Desidustat group: will receive 100mg orally three times a week on non-consecutive days
Control Intervention1: Darbepoetin alfa: Darbepoetin alfa Will receive 0.45mcg/kg once weekly or
Sponsors
Dr Nithya T
Eligibility
Inclusion criteria
Inclusion criteria: 1.All stable outpatients with chronic kidney disease (CKD) stage 2 4 , not on dialysis, aged between 18-75 years ,with moderate anemia (8-10g/dl) and severe anemia (6.5-7.9 g/dl). 2.Willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1.Recent use of erythropoiesis -stimulation agents (ESAs) 2.Recent blood transfusion within 8 weeks. 3. History of any active or recent malignancy within 5 years. 4.Pregnant or lactating. 5.History of thrombotic disorders, thromboembolism in the past. 6.Patients with iron deficiency, B12 deficiency have been ruled out
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobin levels ,iron indices and RBC indices.Timepoint: Period of 12 weeks to assess the Hb, iron indicies, RBC indices level at baseline, 8th week and 12th week in both the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving target hemoglobin. Assessment of adverse drug reaction such as alteration of liver enzymes (SGOT,SGPT )and serum electrolytes are recorded during the study. Assessment of inflammatory biomarkers such as C-reactive protein(CRP) and erythrocyte sedimentation rate (ESR )levels and oxidative stress markers(MDA,MDO). Timepoint: At 8th week and 12th week. | — |
Countries
India
Contacts
Public ContactDr Sumitha A
Department of Pharmacology, A C S Medical College and Hospital
Outcome results
None listed