Actively Recruiting
A Phase III, Randomized, Investigator-Blinded, Active-Controlled Study of Efficacy and Safety of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
Led by Genexine, Inc. · Updated on 2026-05-22
429
Participants Needed
58
Research Sites
39 weeks
Total Duration
On this page
Sponsors
G
Genexine, Inc.
Lead Sponsor
P
PT Kalbe Genexine Biologics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. This Phase III, investigator-blinded, randomized, multicenter study compares two drugs, efepoetin alfa and darbepoetin alfa, to see how well they maintain hemoglobin levels in these patients. The study aims to maintain hemoglobin between 10.0 g/dL and 12.0 g/dL, which is important for managing anemia in CKD. Participants will be randomly assigned in a 2:1 ratio to receive either efepoetin alfa or darbepoetin alfa. Both drugs are given by intravenous injection, typically after dialysis sessions. Efepoetin alfa is administered weekly from Day 1 to Week 28, with possible interval changes to one or two weeks from Week 29 to Week 52 based on investigator judgment. The study consists of three periods: screening (up to 28 days), treatment (about 52 weeks), and a 4-week follow-up with phone contacts up to Week 56 or the last visit. During the study, participants will undergo regular assessments including hemoglobin level monitoring to evaluate the mean change between Week 20 and Week 28. Safety and efficacy are closely observed, with dosages adjusted to maintain target hemoglobin levels. Follow-up will include phone contacts to monitor participants up to Week 56. The total participation duration is approximately one year, starting from screening through treatment and follow-up.
CONDITIONS
Brief Title
A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males and females 18 years or older
- Signed informed consent approved by an Ethics Committee or Institutional Review Board
- Stage 5 chronic kidney disease with estimated GFR 15 mL/min/1.73m2 or less on adequate hemodialysis for at least 12 weeks
- Hemodialysis patients with single-pool Kt/V of 1.2 or higher or urea reduction ratio 65% or higher
- Stable doses of intravenous erythropoiesis-stimulating agents (ESA) for at least 6 weeks prior to Day 1
- Hemoglobin levels between 9.0 g/dL and 12.0 g/dL with less than 1.5 g/dL difference between recent values
- Serum ferritin 100 ng/mL or higher
- Transferrin saturation 20% or higher
- Serum folate and vitamin B12 concentrations at or above the lower limit of normal at screening
You will not qualify if you...
- Active acute or chronic infection or uncontrolled inflammatory disease that may affect red blood cell production
- Active acute hepatitis B or C infection, or chronic infection with abnormal liver tests
- Known HIV positive status
- History or clinical evidence of cardiovascular, hematologic, hepatic, or other physical conditions compromising study participation
- Liver enzyme levels above 3 times upper normal limits or total bilirubin above 1.5 times normal
- Chronic congestive heart failure class III or IV
- High risk for early study withdrawal due to recent heart attack, unstable coronary disease, stroke, or severe liver disease
- Uncontrolled hypertension with blood pressure above 170/100 mmHg
- History of active cancer except certain cured or in remission types
- Recent significant bleeding episodes within 8 weeks
- Known blood diseases other than CKD-related anemia
- Prior or planned organ transplant or anephric state
- Planned surgery leading to significant blood loss during study
- Low serum albumin below 2.5 g/dL
- Use of certain therapies like androgen or iron chelators within 12 weeks prior to Day 1
- Life expectancy under 12 months
- Cognitive or psychiatric conditions preventing cooperation
- Hypersensitivity to study drugs or their components
- Recent blood transfusions or anticipated need during study
- Recent immunosuppressive therapy except corticosteroids
- History of alcohol or drug abuse within past 2 years
- Participation in other investigational studies or treatments
- Females of childbearing potential or males unwilling to use contraception during and after study
- Study site staff or family members involved in the trial
- Very limited functional capacity
- Weight over 150 kg or other safety concerns as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants continue their current treatment during screening.
Duration - Up to 52 weeks
Participants discontinue prior erythropoietin treatment and are randomized to receive efepoetin alfa or darbepoetin alfa to maintain hemoglobin levels between 10.0 g/dL and 12.0 g/dL.
Weekly intravenous injections from Day 1 to Week 28, then injections every 1 or 2 weeks from Week 29 to Week 52 based on investigator's judgment.
Duration - 4 weeks
Participants are monitored by phone contacts after treatment ends to assess safety and outcomes.
Phone contacts up to Week 56 or at last patient's Week 56 visit.
Trial Site Locations
Total: 58 locations
1
"ARABKIR" Joint Medical Center & Institute of Child and Adolescent Health
Yerevan, Armenia
Actively Recruiting
2
"BEST LIFE" Medical Center Armenian-Japanese Joint Venture LLC
Yerevan, Armenia
Actively Recruiting
3
'Astghik'' Medical Center
Yerevan, Armenia
Actively Recruiting
4
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad, Bulgaria
Actively Recruiting
5
Department of Dialysis Treatment, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich
Dobrich, Bulgaria
Actively Recruiting
6
Department of Nephrology, Dialysis Treatment, Multiprofile Hospital for Active Treatment "Dr. Tota Venkova" AD, Gabrovo
Gabrovo, Bulgaria
Actively Recruiting
7
First Dialysis Services Bulgaria EAD, branck Montana
Montana, Bulgaria
Actively Recruiting
8
Diaslys Center - Pazardzhik
Pazardzhik, Bulgaria
Actively Recruiting
9
Department of Dialysis Treatment, Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv
Plovdiv, Bulgaria
Actively Recruiting
10
First Dialysis Services Bulgaria EAD, Plovdiv
Plovdiv, Bulgaria
Actively Recruiting
11
Department of Dialysis Treatment, University Multiprofile Hospital for Active Treatment "Medica Ruse" OOD, Ruse
Rousse, Bulgaria
Actively Recruiting
12
Department of Dialysis Treatment, Multiprofile Hospital for Active Treatment "Dr. Ivan Selimski - Sliven" AD, Sliven
Sliven, Bulgaria
Actively Recruiting
13
Acibadem CityClinic UMHAT Tokuda EAD
Sofia, Bulgaria
Actively Recruiting
14
Dialysis Center - Dialmed
Sofia, Bulgaria
Actively Recruiting
15
Dialysis Center Hemomed EOOD
Sofia, Bulgaria
Actively Recruiting
16
Multiprofile Hospital for Active Treatment Sveta Anna - Varna AD
Varna, Bulgaria
Actively Recruiting
17
Nemocnice Cesky krumlov
Český Krumlov, Czechia
Actively Recruiting
18
Nemocnice Havlíčkův Brod
Havlíčkův Brod, Czechia
Actively Recruiting
19
HDS Privamed Healthia sro v Plzni
Pilsen, Czechia
Actively Recruiting
20
B. Braun Avitum s.r.o - Dialyzacni stredisko Teplice - Nefrologicka ambulance
Teplice, Czechia
Actively Recruiting
21
Batumi Dialysis and Nephrology Center
Batumi, Georgia
Completed
22
Clinical Center for Nephrology Development
Tbilisi, Georgia
Completed
23
L.Managadze National Center of Urology
Tbilisi, Georgia
Completed
24
Tbilisi Heart And Vascular Clinic
Tbilisi, Georgia
Completed
25
RSUP Dr. Hasan Sadikin
Bandung, Indonesia
Completed
26
RS Islam Jakarta Cempaka Putih
Jakarta, Indonesia
Completed
27
RSPAD Gatot Soebroto
Jakarta, Indonesia
Completed
28
RSUPN Dr. Cipto Mangunkusumo
Jakarta, Indonesia
Completed
29
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia- Unità Operativa (UO) Nefrologia
Brescia, Italy
Actively Recruiting
30
SODc Nefrologia Dialisi Trapianto Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Actively Recruiting
31
"Azienda Ospedaliero Universitaria ""Ospedali Riuniti"" di Foggia Unità Operativa Complessa di Nefrologia, Dialisi e Trapianto"
Foggia, Italy
Actively Recruiting
32
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Actively Recruiting
33
ICS Maugeri
Pavia, Italy
Actively Recruiting
34
AOU Pisana UO Nefrologia Trapianti e Dialisi
Pisa, Italy
Actively Recruiting
35
AOU Integrata di Verona UOC Nefrologia
Verona, Italy
Actively Recruiting
36
Wojewodzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku
Bialystok, Poland
Actively Recruiting
37
DaVita Stacja Dializ Brodnica
Brodnica, Poland
Actively Recruiting
38
Samodzielny Publiczny Zakład Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, Poland
Actively Recruiting
39
DaVita Sp. z o.o. Pszczyna
Pszczyna, Poland
Actively Recruiting
40
DaVita Stacja Dializ WADOWICE
Wadowice, Poland
Actively Recruiting
41
DaVita sp. z o.o. Warszawa Mangalia
Warsaw, Poland
Actively Recruiting
42
DaVita Stacja Dializ Warszawa
Warsaw, Poland
Actively Recruiting
43
DaVita Sp. z o.o. Zyrardow
Żyrardów, Poland
Actively Recruiting
44
Clinic for Nephrology, Clinical Hospital Center Zvezdara
Belgrade, Serbia
Actively Recruiting
45
Clinic for Nephrology and Dialysis, University Clinical Center Kragujevac
Kragujevac, Serbia
Actively Recruiting
46
Clinic for Nephrology and Dialysis, University Clinical Center Nis
Niš, Serbia
Actively Recruiting
47
Korea University Ansan Hospital
Ansan, South Korea
Completed
48
St Mary's Incheon Hospital
Incheon, South Korea
Completed
49
Kangdong KyungHee University Hospital
Seoul, South Korea
Completed
50
St Mary's Seoul Hospital
Seoul, South Korea
Completed
51
St Mary's Yeouido Hospital
Seoul, South Korea
Completed
52
Hualien Tzu Chi Hospital
Hualien City, Taiwan
Actively Recruiting
53
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Actively Recruiting
54
Shuang Ho Hospital
New Taipei City, Taiwan
Actively Recruiting
55
Taipei Medical University Hospital
Taipei, Taiwan
Actively Recruiting
56
Ege University Faculty of Medicine Hospital
Izmir, Turkey (Türkiye)
Completed
57
Erciyes University Faculty of Medicine Hospital
Kayseri, Turkey (Türkiye)
Completed
58
Kocaeli University Faculty of Medicine Hospital
Kocaeli, Turkey (Türkiye)
Completed
Research Team
Y
Yoon-Jeong Choi
T
TaeKyung Seong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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