Post-marketing SurveillanceStudy in patients prescribed with Darbepoetin alfa

Phase 4

Completed

Conditions: Anemia in chronic kidney disease, Chronic Kidney Disease with Anemia,

Brief Summary: This is an Open-labelled, prospective, observational, post-marketing surveillance study in patients prescribed with Hetero-Darbepoetin alfa. All patients prescribed Hetero-Darbepoetin alfa by their treating physician will constitute the target patient population. Each treating doctor will report his/ her experience with patient(s) treated with Hetero-Darbepoetin alfa. Hetero- Darbepoetin alfa will be prescribed in the dosage and for the duration as recommended in the package insert or as per the discretion of the prescribing investigator and as per the inclusion and exclusion criteria.

Recruitment & Eligibility

Inclusion Criteria

Male and female adult patients.
Patients need to be administered Hetero-Darbepoetin alfa in order to be enrolled in the surveillance.
Patients of (CKD) suffering from renal anemia.
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.
Any other patient to be prescribed Hetero-Darbepoetin alfa as per prescribing physicianâ€™s discretion as per prescribing information.

Exclusion Criteria

Patients not administered/ contraindicated Hetero-Darbepoetin alfa.
Patients who are likely to be pregnant or lactating patients.
Patients with clinical history/ evidence of allergy/ hypersensitivity to components of Hetero-Darbepoetin alfa.
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.

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 events	All visits

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Locations (18): Bodyline Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Care Hospital
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Fortis Hospitals Limited
🇮🇳
Bangalore, KARNATAKA, India
GSVM Medical College
🇮🇳
Nagar, UTTAR PRADESH, India
Institute of Post Graduate Medical Education and Research
🇮🇳
Kolkata, WEST BENGAL, India
Jeevan Jyoti Multispeciality Hospital
🇮🇳
Allahabad, UTTAR PRADESH, India
King George Hospital
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Max Super Speciality Hospital
🇮🇳
Delhi, DELHI, India
Medlink Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Nirmal Hospital
🇮🇳
Jhansi, UTTAR PRADESH, India
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Bodyline Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Javed M Vakil
Principal investigator
07933012372
drjmvakil@gmail.com