A Phase 3 interventional study of Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. and Active comparator: European Union licenced epoetin alfa in Anemia of Chronic Kidney Disease, sponsored by Megalabs. Not yet recruiting at 1 site in Uruguay. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Megalabs · Phase 3, Interventional, and Treatment
Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis
Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. Hemoglobin, hematocrit and reticulocyte counts will be assessed. Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination. Test drug and comparator drug will be compared to evaluate biosimilarity.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 280 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →Megalabs is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Epoetin alfa Megalabs, Human recombinant epoetin alfa
Biological: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.
USA licenced Epoetin alfa, Epogen®, Human recombinant epoetin alfa
Biological: Active comparator: European Union licenced epoetin alfa
comparison vs the reference product to demonstrate biological similarity
Also known as: Epoetin alfa Megalabs®, Human recombinant epoetin alfa
comparison vs. the test product to demonstrate biological similarity
Also known as: Epogen®, Human recombinant epoetin alfa
Mean Absolute Change in Hemoglobin Levels
Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements. Hemoglobin is the primary endpoint of the study .
Time frame: 18 months
Change in Mean Hb Level
Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements. Hemoglobin is the primary endpoint of the study.
Time frame: 18 months
immunogenicity
Anti-drug antibodies will be assessed in both groups every two weeks.
Time frame: 18 months
Plan to share: No
Start is estimated for Jul 2025; primary completion for Mar 2027, 20 months later.
Of 98 industry-sponsored phase 3 interventional studies under Anemia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's planned 20 months is below that.
Counting every sponsor, half of 150 studies reached it within 30 months; a quarter within 17 and three quarters within 51.
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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