391
Participants
Start Date
July 2, 2020
Primary Completion Date
March 30, 2022
Study Completion Date
June 30, 2023
efepoetin alfa
The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period.
Mircera
The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL.
Changhua Christian Hospital, Changhua
National Taiwan University Hospital, Taipei
Tri-Service General Hospital, Taipei
Keelung Chang Gung Memorial Hospital, Keelung
Far Eastern Memorial Hospital, Taipei
Taipei Medical University - Shuang Ho Hospital, Taipei
Kuang Tien General Hospital, Taichung
Chi Mei Medical Center, Tainan City
National Cheng Kung University Hospital, Tainan City
Kaohsiung Veterans General Hospital, Kaohsiung City
Linkou Chang Gung Memorial Hospital, Taoyuan District
Hualien Tzu Chi Hospital, Hualien City
National Kidney and Transplant Institute, Quezon
Renal Research Gosford, Gosford
Baguio General Hospital Medical Center, Baguio City
De La Salle Medical and Health Sciences Institute, Dasmariñas
Royal Adelaide Hospital, Adelaide
West Visayas State University Hospital, Iloilo City
Norzel Medical and Diagnostic Clinic, Cebu City
M3 Dialysis Center, Bacolod City
Launceston General Hospital, Launceston
Davao Doctors Hospital, Davao City
Vajira Hospital, Bangkok
Siriraj Hospital, Bangkok
Thammasat University Hospital, Pathum Thani
Hospital Raja Perempuan Zainab II, Kota Bharu
Hospital Tengku Ampuan Afzan, Kuantan
Hospital Raja Permaisuri Bainun, Ipoh
Seri Manjung Hospital, Seri Manjung
Sunpasitthiprasong Hospital, Ubon Ratchathani
Taiching Veterans General Hospital, Taichung
Hospital Kajang, Kajang
Hospital Serdang, Serdang
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai
Hospital Kuala Lumpur, Kuala Lumpur
University of Malaya Medical Centre, Kuala Lumpur
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
Kaohsiung Chang Gung Hospital, Kaohsiung City
Songklanagarind Hospital, Songkhla
Hospital Sibu, Sibu
Rspad Gatot Soebroto, Jakarta Pusat
Rumah Sakit Islam Jakarta Cempaka Putih, Jakarta Pusat
Rumah Sakit Islam Jakarta Pondok Kopi, Jakarta Pusat
Rumah Sakit Pgi Cikini, Jakarta Pusat
Rumah Sakit Umum Pusat Fatmawati, Jakarta Pusat
Rumah Sakit Umum Pusat Nasional Dr Cipto Mangunkusumo, Jakarta Pusat
Chungnam National University Hospital, Daejeon
Korea University Ansan Hospital, Gyeonggi-do
Seoul National University Bundang Hospital, Gyeonggi-do
The Catholic University of Korea Incheon St. Mary'S Hospital, Incheon
Chungnam National University Sejong Hospital, Sejong
Kyung Hee University Hospital At Gangdong, Seoul
The Catholic University of Korea Eunpyeong St. Mary'S Hospital, Seoul
The Catholic University of Korea Seoul St. Mary'S Hospital, Seoul
The Catholic University of Korea, Yeouido St. Mary'S Hospital, Seoul
Novotech (Australia) Pty Limited
INDUSTRY
PT Kalbe Genexine Biologics
INDUSTRY