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Search / Trial NCT06352138

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.

Locations

Colonia Nicolich, Canelones, Uruguay

Patients applied

0 patients applied

Trial Officials

Satish Kumar, MD

Study Director

Azidus Principal Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported