Last updated 4 months ago

Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients

280 patients around the world
Available in Uruguay
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.
Megalabs
1Research sites
280Patients around the world

This study is for people with

Renal disease
Chronic kidney disease

Requirements for the patient

To 65 Years
All Gender

Medical requirements

Stage V Chronic kidney disease undergoing hemodialysis.
Lack of consent to participate in the trial.
Other severe chronic disease.
History of pure red cell aplasia.
Existence of anti erythropoietin antibodies.

Sites

Megalabs
Cno. Maldonado 5634, 12100 Montevideo, Departamento de Montevideo, Uruguay
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