Post-marketing SurveillanceStudy in patients prescribed with Darbepoetin alfa
- Conditions
- Health Condition 1: D631- Anemia in chronic kidney diseaseHealth Condition 2: null- Chronic Kidney Disease with Anemia
- Registration Number
- CTRI/2017/04/008338
- Lead Sponsor
- Hetero Drugs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 503
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.
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ot applicableTimepoint: Not applicable