Health Condition 1: D631- Anemia in chronic kidney disease Health Condition 2: null- Chronic Kidney Disease with Anemia
Conditions
Interventions
Intervention1: Darbepoetin alfa: Subcutaneous administration of Darbepoetin alfa 0.45 µg/kg body weight, as a single injection once weekly.
Control Intervention1: Not applicable: Not applicable
Sponsors
Hetero Drugs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female adult patients. 2. Patients need to be administered Hetero-Darbepoetin alfa in order to be enrolled in the surveillance. 3. Patients of (CKD) suffering from renal anemia. 4. Treatment of anemia due to the effect of concomitantly administered chemotherapy in patients that have shown a reduction in the need for RBC transfusions in patients with metastatic, non-myeloid malignancies. 5. Any other patient to be prescribed Hetero-Darbepoetin alfa as per prescribing physician’s discretion as per prescribing information.
Exclusion criteria
Exclusion criteria: 1. Patients not administered/ contraindicated Hetero-Darbepoetin alfa. 2. Patients who are likely to be pregnant or lactating patients. 3. Patients with clinical history/ evidence of allergy/ hypersensitivity to components of Hetero-Darbepoetin alfa. 4. Patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy 5. Patients receiving myelosuppressive therapy when the anticipated outcome is cure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and laboratory adverse events including incidence, severity duration, outcome, action taken and causality parameters of serious and non-serious adverse eventsTimepoint: All visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha MD
Hetero Drugs Limited
Outcome results
None listed