New Vikas Gurh Road, opp Annapurna Hall, Paldi-7, Ahmedabad, Gujurat Ahmadabad GUJARAT
07933012372
drjmvakil@gmail.com
Dr P Vikranth Reddy
Care Hospital
Cabin No: 434, 3rd floor, B-block, Care Out Patient Center, Road No: 10, Beside Karvy Head Office, Banjara Hills, Hyderabad
Pin: 500034 Hyderabad ANDHRA PRADESH
914039116000
vikranthreddy@yahoo.com
Dr R Sreedhara
Fortis Hospitals Limited
154/9, Bannerghatta Road, Opp.IIM-B, Bangalore-560076, Karnataka, India Bangalore KARNATAKA
Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital Situated at Srikakulam-532001, Andhra Pradesh, India ECR/492/Inst/AP/2013
Approved
Ethics Committee, Sir Ganga Ram Hospital Ethics Committee, Room No 1496. IV Floor , Old Building ,Sir Ganga Ram Hospital , Old Rajinder Nagar ,New Delhi-110060 ECR/20/Inst/DL/2013
Institute Ethics Committee ,SGPGI Bioethics Cell, Room No. 205,Ist Floor ,Administrative Block ,Sanjay Gandhi Post graduate Institute of Medical Sciences , Raebareli Road , Lucknow , U.P India Pin-2260147 ECR/16/Inst/UP/2013
Submittted/Under Review
Institutional Ethics Committee Situated at M/s. King George Hospital, Visakhapatnam - 530002, Andhra Pradesh ECR/197/Inst/KGH/2013
Approved
Institutional Ethics Committee, Jeevan Jyoti Hospital & Research Centre, 1625, Bai Ka Bagh, Lowther road, Allahabad 211003 ECR/285/Inst/UP/2013
Approved
Institutional Ethics Committee, Nirmal Hospital, Nirmal Hospital campus Gate No. 3, opp MLB Medical College Gate No. 3 Jhansi-284128 (U.P) ECR/325/Inst/UP/2013
Submittted/Under Review
Institutional Ethics Committee,Max Healthcare Super Speciality Hospital, 6th floor 2, Press Enclave Road, Saket, New Delhi-110017 ECR/110/Inst/DL/2013
Approved
IPGME&R Research Oversight Committee, Institute of Post graduate medical Education and Research 244 J.C Bose Road, Kolkata -700020 ECR/35/Inst/WB/2013
Submittted/Under Review
Medlink Ethics Committee, Basement Medlink Hospital, Nr. Shyamal Cross Road, 132 ft. ring Road, Satellite, Ahmedabad-380015 ECR/344/Inst/GJ/2013
Approved
Rangadore Memorial Hospital Ethics Committee (RMHEC) Situated at Rangadore Memorial Hospital, 1st Cross, Shankrapuram, Basavanagudi, Bangalore-560004, Karnataka, India ECR/507/Inst/KA/2014
Submittted/Under Review
Sangini Hospital Ethics Committee, C/O Sangini Hospital, 2nd Floor, Sangini Complex, Near Doctor House, Primal Crossing Ahmedabad ECR/147/Inst/GJ/2013
Submittted/Under Review
Sapthagiri Institute Of Medical Sciences and Research Center #15, Chikkasandra, Hesaraghatta Main Road, Bangalore, Karnataka 560090 ECR/330/Inst/KA/2013
Submittted/Under Review
The Chairperson, TANKER Foundation Institutional Ethics Committee, TANKER Foundation, 17, Wheatcrofts road, Nungambakkam, Chennai-600034 ECR/172/Inst/TN/2013
(1) ICD-10 Condition: D631||Anemia in chronic kidney disease, Chronic Kidney Disease with Anemia,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Darbepoetin alfa
Subcutaneous administration of Darbepoetin alfa 0.45 μg/kg body weight, as a single injection once weekly.
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
11.00 Year(s)
Age To
85.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
Not applicable
Not applicable
Target Sample Size
Total Sample Size="500" Sample Size from India="500" Final Enrollment numbers achieved (Total)= "503" Final Enrollment numbers achieved (India)="503"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.