Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

PHASE3CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

October 9, 2021

Study Completion Date

October 9, 2021

Conditions
Renal Anemia
Interventions
DRUG

EPREX®

"Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease.~Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000."

DRUG

EPIAO®

"Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease.~Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000."

Trial Locations (19)

10700

Bamrasnaradura Infectious Disease Institute, Bangkok

Bhumibol Adulyadej hospital, Bangkok

BMA hospital, Bangkok

Chulalongkorn King Memorial hospital, Bangkok

Klongton Hospital, Bangkok

Phramongkutklao hospital, Bangkok

Rajavithi hospital, Bangkok

Siriraj Hospital, Bangkok

129110

"State budgetary healthcare institution of Moscow region Moscow Regional Scientific Research and Clinical Institute named after M.F.Vladimirsky, Department of Transplantation, nephrology and surgical hemocorrection", Moscow

185019

"State Budgetary Healthcare Institution of the Republic of Karelia V.A. Baranov Republican Hospital", Moscow

191015

"State Budgetary Educational Institution of Higher Professional Education North-Western State Medical University named after I.I. Mechnikov Ministry of Health of Russian Federation", Saint Petersburg

"The Federal State Budgetary Institute The Nikiforov Russian Center of Emergency and Radiation Medicine of the Ministry of Russian Federation for Civil Defense, Emergencies and Elimination of Consequences of Natural Disasters", Saint Petersburg

191104

"St- Petersburg state budgetary healthcare institution City Mariinsky Hospital, department of hemodialysis", Saint Petersburg

192242

"State budgetary institution St-Petersburg' scientific-research institution of emergency n.a Dzanelidze)", Saint Petersburg

195427

"St-Peterburg State healthcare institution Municipal hospital of Elizabethan Hospital", Saint Petersburg

198205

"Saint-Petersburg State Budgetary Healthcare Institution City Hospital No. 15", Saint Petersburg

404120

"State Budgetary Healthcare Institution Volgogradskiy Regional Center of Urology and Nephrology", Volzhsky

443099

"Federal State Institution of Higher Education Samara State Medical University of the Ministry of Health of the Russian Federation", Samara

460040

"State budgetary healthcare institution City Clinical Hospital № 1 of Orenburg", Orenburg

Sponsors
All Listed Sponsors
collaborator

Navitas Life Sciences GmbH

INDUSTRY

lead

Shenyang Sunshine Pharmaceutical Co., LTD.

INDUSTRY

NCT02947438 - Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study) | Biotech Hunter | Biotech Hunter