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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoetin alfa Megalabs® injectable in intravenous application. | Experimental | Epoetin alfa Megalabs, Human recombinant epoetin alfa |
|
| Epoetin alfa Epogen® injectable in intravenous application. | Active Comparator | USA licenced Epoetin alfa, Epogen®, Human recombinant epoetin alfa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. | Biological | comparison vs the reference product to demonstrate biological similarity |
| Measure | Description | Time Frame |
|---|---|---|
| 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 . | 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| immunogenicity | Anti-drug antibodies will be assessed in both groups every two weeks. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcos Giusti, MD | Contact | 59826838000 | mgiusti@megalabs.global | |
| Victoria Rodriguez, MD | Contact | 59826838000 | vrodriguez@megalabs.global |
| Name | Affiliation | Role |
|---|---|---|
| Satish Kumar, MD | Azidus Principal Investigator | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Megalabs | Colonia Nicolich | Departamento de Canelones | 15000 | Uruguay |
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| Label | URL |
|---|---|
| reference guideline | View source |
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multicentre, double-blind, randomised, parallel, equivalence trial
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|
| Active comparator: European Union licenced epoetin alfa | Biological | comparison vs. the test product to demonstrate biological similarity |
|
|
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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