Actively Recruiting
A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
Led by Genexine, Inc. · Updated on 2024-06-24
429
Participants Needed
9
Research Sites
187 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
An investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis
CONDITIONS
Official 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 60; 18 years old.
- Patient or legally acceptable representative signed informed consent.
- Stage 5 CKD with estimated GFR 60; 15 mL/min/1.73m2 on adequate hemodialysis for at least 12 weeks.
- Hemodialysis patients with single-pool Kt/V 60; 1.2 or urea reduction ratio 60; 65%.
- Stable doses of intravenous erythropoiesis-stimulating agents for at least 6 weeks prior to Day 1.
- Hemoglobin levels between 9.0 and 12.0 g/dL with less than or equal to 1.5 g/dL variation between two recent values.
- Serum ferritin 60; 100 ng/mL at screening.
- Transferrin saturation (TSAT) 60; 20% at screening.
- Serum folate concentrations at or above the lower limit of normal.
- Serum total vitamin B12 concentrations at or above the lower limit of normal.
You will not qualify if you...
- Active acute or chronic infection or uncontrolled symptomatic inflammatory disease (other than glomerulonephritis) affecting red blood cell production.
- Active acute hepatitis B or C infection or chronic HBV/HCV with liver function tests greater than 3 times normal.
- Known HIV positive status.
- Cardiovascular, hematologic, hepatic, or physical conditions compromising study participation.
- Laboratory abnormalities: ALT or AST greater than 3 times upper limit of normal, total bilirubin greater than 1.5 times upper limit.
- Chronic congestive heart failure class III or IV.
- High risk of early withdrawal due to recent severe cardiovascular or liver events.
- Uncontrolled hypertension with systolic 60; 170 mmHg or diastolic 60; 100 mmHg.
- History of active malignancy not cured or in remission less than 5 years.
- Recent overt gastrointestinal or other bleeding causing hemoglobin drop 60; 1 g/dL within 8 weeks.
- History of myelodysplastic syndrome, multiple myeloma, hereditary blood diseases, or other anemia causes besides CKD.
- Prior or planned organ transplantation or anephric state.
- Planned elective surgery causing significant blood loss during study.
- Hypoalbuminemia (serum albumin less than 2.5 g/dL).
- Recent use of androgens or iron chelation therapy within 12 weeks.
- Life expectancy less than 12 months.
- Cognitive or psychiatric conditions impairing study cooperation.
- Hypersensitivity to study drugs or excipients.
- Blood transfusion within 12 weeks or expected during study.
- Recent immunosuppressive therapy other than corticosteroids.
- History of alcohol or drug abuse in past 2 years with inability to limit alcohol intake.
- Use of investigational treatments or participation in other interventional studies.
- Females of childbearing potential or males not using adequate contraception during and after study.
- Pregnant, breastfeeding, or planning pregnancy within 12 months.
- Investigational site staff or family members involved in the trial.
- Very limited functional capacity affecting treatment benefit.
- Patients weighing over 150 kg or with medical conditions posing safety risks or interfering with study participation.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Batumi Dialysis and Nephrology Center
Batumi, Georgia
Actively Recruiting
2
Clinical Center for Nephrology Development
Tbilisi, Georgia
Actively Recruiting
3
L.Managadze National Center of Urology
Tbilisi, Georgia
Actively Recruiting
4
Tbilisi Heart And Vascular Clinic
Tbilisi, Georgia
Actively Recruiting
5
Korea University Ansan Hospital
Ansan, South Korea
Actively Recruiting
6
St Mary's Incheon Hospital
Incheon, South Korea
Actively Recruiting
7
Kangdong KyungHee University Hospital
Seoul, South Korea
Actively Recruiting
8
St Mary's Seoul Hospital
Seoul, South Korea
Actively Recruiting
9
St Mary's Yeouido Hospital
Seoul, South Korea
Actively Recruiting
Research Team
Y
Yoon-Jeong Choi
CONTACT
T
TaeKyung Seong
CONTACT
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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