Last updated on May 2018

Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)


Brief description of study

This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO and EPREX in terms of 52-week comparisons in efficacy, safety and immunogenicity. The targeted population is anaemia patients with end-stage chronic renal disease who previously received epoetin treatment and on haemodialysis.

Detailed Study Description

This is a prospective, randomized, double blind, parallel group two arm study to establish the therapeutic equivalence, safety and tolerability of EPIAO as compared to EPREX in the treatment of CKD related anaemia in subjects who are on haemodialysis. A total of 264 subjects will be randomized into two groups in a 1:1 ratio. Treatment arm A will receive EPIAO 1-3 times a week, intravenously for period of 52 weeks and treatment arm B will receive EPREX, 1-3 times a week, intravenously for period of 52 weeks.

Clinical Study Identifier: NCT02947438

Contact Investigators or Research Sites near you

Start Over

Wisit Prasithsirikul, doctoral

Bamrasnaradura Infectious Disease Institute
Bangkok, Thailand
  Connect »

Pongsathorn Gojaseni, doctoral

Bhumibol Adulyadej hospital
Bangkok, Thailand
  Connect »

Somphon Buranaosot, doctoral

BMA hospital
Bangkok, Thailand
  Connect »

Khajohn Tiranathanagul, doctoral

Chulalongkorn King Memorial hospital
Bangkok, Thailand
  Connect »

Wanida Kasemchotipatana, doctoral

Klongton Hospital
Bangkok, Thailand
  Connect »

Theerasak Tongwonglert, doctoral

Phramongkutklao hospital
Bangkok, Thailand
  Connect »

Udom Krairittichai, doctoral

Rajavithi hospital
Bangkok, Thailand
  Connect »

Kriengsak Vareesangthip, doctoral

Siriraj Hospital
Bangkok, Thailand
  Connect »

BOLONG MIAO, Doctoral

State Budgetary Healthcare Institution "Volgogradskiy Regional Center of Urology and Nephrology"
Volzhskiy, Russian Federation
  Connect »

Vatazin Andrey Vladimirovich, Doctoral

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, Russian Federation
  Connect »

Alexander Zuev, doctoral

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

Alexander Alekseevich Selutin, doctoral

State budgetary healthcare institution "City Clinical Hospital 1" of Orenburg
Orenburg, Russian Federation
  Connect »

Alina Nikolaevna Isachkina, doctoral

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, Russian Federation
  Connect »

Vladimir Yurievich Ryasnanskii, doctoral

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, Russian Federation
  Connect »

Zemchenkov Aleksander Yrievich, Doctoral

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

Victor Petrovich Doru-Tovt, doctoral

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

Olga Mikhailovna Soloveva, doctoral

St-Peterburg State healthcare institution "Municipal hospital of "Elizabethan Hospital
Saint Petersburg, Russian Federation
  Connect »

Konstantin Vishnevskiy, doctoral

Saint-Petersburg State Budgetary Healthcare Institution "City Hospital No. 15"
Saint Petersburg, Russian Federation
  Connect »

Igor Leonidovich Davydkin, doctoral

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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.