Ethics approval and consent to participate
The study was conducted in accordance with the ethical guidelines outlined in the Declaration of Helsinki, 1964 as revised in 2013, Schedule Y along with subsequent amendments and Indian regulatory laws governing biomedical research in human patients. Institutional ethics committee approval was obtained from each participating study center before initiating the study. The study was an observational, non- interventional postmarketing surveillance (PMS) study based on prescribed usage of the darbepoetin alpha in patients having diseases as per approved indications. As per the applicable regulatory guidelines, written informed consent is not mandatory to be obtained from the subjects in who are being prescribed the marketed study drug in these studies. However, for the purpose of good documentation practices & upholding the ethics considerations, written informed consent was obtained from each subject before enrolling them into the study. The study was registered with the clinical trial registry (CTRI/2017/04/008338) retrospectively.
Ethics committee name and address
- Institutional Ethics Committee Situated at M/s. King George Hospital, Vishakhapatnam-530002, Andhra Pradesh. ECR/197/Inst/KGH/2013
- Ethics Committee St. Thereas’s Hospital Erragadda Santhnagar Hyderabad – 500018, Andhra Pradesh. ECR/230/Inst/AP/2013
- Bodyline Hospital, Institution Ethics Committee opp Annapurna Hall, Nr. Dev Status, Vikas Gruh road, Paldi, Ahmedabad, Gujurat. ECR/476/Inst/GJ/2013
- Medilink Ethics Committee, Basement Medilink Hospital, Nr. Shyamal Cross Road, 132 ft. ring Road, Satellite, Ahmedabad-380015. ECR/344/Inst/GJ/2013
- Ethics Committee GSVM Medical College, Opp. CRS Complex GSVM Medical college, Kanpur-208005. ECR/680/Inst/UP/2014
- Fortis Hospital Ethics Committee 154/9 Bannerghatta Road, Opp IIM-B, Bangalore-560076, Karnataka. ECR/378/Inst/KA/2013
- Care Hospital Care Convergence Centre, H. No. 8-2-595/2/B, Road No. 10, Banjara Hills, Hyderabad-500034. ECR/94//Inst/AP/2013
- Ethics Committee Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital Situated at Srikakulam-532001, Andhra Pradesh, India. ECR/492/Inst/AP/2013
- Institutional Ethics Committee, Jeevan Jyoti Hospital & Research Centre, 1625, Bai Ka Bagh, Lowther road, Allahabad 211003. ECR/285/Inst/UP/2013
Consent for publication
Not applicable
Availability of data and materials
Data supporting the findings are presented within the manuscript and additional datasets used are available from the corresponding author on request.
Competing interests
SD, VB, BB, PT, SC, LT, SK, PD and SS are the employees of Hetero Biopharma Limited, India
and involved from conception of study to the approval of the manuscript. All the authors declare no other competing interests.
Funding
This study was sponsored by Hetero Biopharma Limited, India including the study related materials and study drugs. The study was designed and executed by Hetero Biopharma Limited, India in line with local and international regulatory requirements. The publication of this manuscript is funded by the Hetero Biopharma Limited, all the authors are the employees of the Hetero and were involved in the design of the study and the collection, analysis, and interpretation of data and writing the manuscript.
Authors’ contributions:
Concept and design of trial, SD, VB, BB, SC, PT: Overall project management, data collection, statistical analysis, data interpretation and conclusion analysis, drafting of manuscript, revising manuscript: SD, SC, PT, LT, SK, PD, SS, corresponding author: PT. All authors read and approved the final manuscript.
Acknowledgements
Authors would like to thank Darbepoetin investigator group (Dr. Ramesh Chandra, Dr. B. Sudhakar, Dr. Javed M. Vakil, Dr. Bhavin Mehtalia, Dr. Vishal Kumar Gupta, Dr. R. Sreedhara, Dr. P. Vikranth Reddy, Dr. P. Sarat Jyostna, Dr. Anurag Singh) for conducting this study. Authors would also like to thank all the study subjects for their valuable participation in this study.
Author details
1Clinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Andhra Pradesh, India.