Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
Launched by MEGALABS · Apr 1, 2024
Trial Information
Current as of June 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different medications, Megalabs® recombinant human alfa epoetin and Epogen®, to see how well they treat anemia in patients with chronic kidney disease who are on hemodialysis (a treatment that helps filter waste from the blood). The goal is to find out if Megalabs® is as effective and safe as Epogen® for managing this condition.
If you or a family member has stage V chronic kidney disease and is currently receiving hemodialysis, you may be eligible to participate in this study. Participants will be randomly assigned to receive one of the two medications, and neither the participants nor the healthcare providers will know which medication is being given to ensure a fair comparison. It's important to note that individuals with severe other health issues or certain specific medical histories will not be able to join the trial. If you decide to participate, you will be monitored closely for how well the treatment works and any possible side effects.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Stage V Chronic kidney disease undergoing hemodialysis
- Exclusion Criteria:
- • Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies
About Megalabs
Megalabs is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a strong commitment to scientific excellence and patient welfare, Megalabs specializes in conducting Phase I-IV clinical trials across various therapeutic areas. The organization leverages cutting-edge technology and a robust network of experienced professionals to ensure the highest standards of quality and compliance. By fostering collaboration with healthcare providers, regulatory bodies, and patients, Megalabs aims to accelerate the delivery of groundbreaking therapies to market, ultimately improving health outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Colonia Nicolich, Canelones, Uruguay
Patients applied
Trial Officials
Satish Kumar, MD
Study Director
Azidus Principal Investigator
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported