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Efepoetin alfa for treatment of anemia in chronic kidney disease on dialysis
EU CTIS ID: 2023-503634-50-00
What this study is testing
To evaluate the efficacy of efepoetin alfa compared to darbepoetin alfa in terms of hemoglobin (Hb) level control (non-inferiority) in hemodialysis patients with anemia due to chronic kidney disease (CKD).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult males and females ≥ 18 years old.
- Serum total vitamin B12 concentrations ≥LLN at screening.
- Patient (or patient’s legally acceptable representative) has voluntarily signed and dated an informed consent form (ICF) approved by an Ethics Committee (EC) or institutional review board (IRB) after the nature of the study has been explained and the patient has had the opportunity to ask questions
- Patient with stage 4 and 5 CKD defined by estimated GFR (eGFR, ≤29 mL/min/1.73m2) on adequate HD for a minimum of 12 weeks prior to Day 1. *CKD staging will be based on the five-stage system for classification of CKD based on KDIGO guidelines.
- Hemodialysis patients with single-pool Kt/V ≥ 1.2 or urea reduction ratio ≥ 65%.
- Patients must be on stable doses of IV injections of ESA (including biosimilars) for at least 6 weeks prior to Day 1. Minimum ESA dose; ✓ Epoetin alfa, epoetin beta, and epoetin kappa: ≥1,500 U/week ✓ Darbepoetin alfa: ≥20 μg/week ✓Mircera®: ≥30 μg/2 weeks
You likely can't join if
- Active acute or chronic infection, or uncontrolled or symptomatic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease), or a C-reactive protein level 40> mg/L (high sensitive C-reactive protein level > 10 mg/L).
- Any of the following laboratory abnormalities at screening visit; • Alanine transaminase (ALT) >3 x upper limit of normal (ULN) • Aspartate aminotransferase (AST) >3 x ULN • Total bilirubin >1.5 x ULN
- Chronic congestive heart failure (New York Heart Association class III or IV).
- Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.
- High risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before Screening or during Screening.
- Uncontrolled hypertension defined as a sitting systolic blood pressure ≥170 mmHg and/or diastolic blood pressure ≥100 mmHg (measure BP in both arms, then the arm that gives the higher reading for subsequent readings).
See the full eligibility criteria
Who can join
- Adult males and females ≥ 18 years old.
- Serum total vitamin B12 concentrations ≥LLN at screening.
- Patient (or patient’s legally acceptable representative) has voluntarily signed and dated an informed consent form (ICF) approved by an Ethics Committee (EC) or institutional review board (IRB) after the nature of the study has been explained and the patient has had the opportunity to ask questions
- Patient with stage 4 and 5 CKD defined by estimated GFR (eGFR, ≤29 mL/min/1.73m2) on adequate HD for a minimum of 12 weeks prior to Day 1. *CKD staging will be based on the five-stage system for classification of CKD based on KDIGO guidelines.
- Hemodialysis patients with single-pool Kt/V ≥ 1.2 or urea reduction ratio ≥ 65%.
- Patients must be on stable doses of IV injections of ESA (including biosimilars) for at least 6 weeks prior to Day 1. Minimum ESA dose; ✓ Epoetin alfa, epoetin beta, and epoetin kappa: ≥1,500 U/week ✓ Darbepoetin alfa: ≥20 μg/week ✓Mircera®: ≥30 μg/2 weeks
- Mean of the 2 most recent local laboratory Hb screening values obtained at least 6 days apart must be 9.0 g/dL to 12.0 g/dL, inclusive, with a difference of ≤1.5 g/dL between the highest and the lowest value.
- Patients with serum ferritin ≥100 ng/mL at screening.
- Patients with transferrin saturation (TSAT) ≥20% at screening.
- Serum folate concentrations ≥lower limit of normal (LLN) at screening.
What rules you out
- Active acute or chronic infection, or uncontrolled or symptomatic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease), or a C-reactive protein level 40> mg/L (high sensitive C-reactive protein level > 10 mg/L).
- Any of the following laboratory abnormalities at screening visit; • Alanine transaminase (ALT) >3 x upper limit of normal (ULN) • Aspartate aminotransferase (AST) >3 x ULN • Total bilirubin >1.5 x ULN
- Chronic congestive heart failure (New York Heart Association class III or IV).
- Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.
- High risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before Screening or during Screening.
- Uncontrolled hypertension defined as a sitting systolic blood pressure ≥170 mmHg and/or diastolic blood pressure ≥100 mmHg (measure BP in both arms, then the arm that gives the higher reading for subsequent readings).
- History of active malignancy except for cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site.
- Patients with a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥1 g/dL within the last 8 weeks prior to Screening.
- Any medical condition (patients weighing over 150 kg) that, in the opinion of the Investigator, may pose a safety risk to a patient in this study, may confound efficacy or safety assessment, or may interfere with study participation.
- Any prior functioning organ transplant or a scheduled organ transplantation, or anephric state (one or both kidneys).
- Planned elective surgery that could lead to significant blood loss during the study period.
- Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to Screening, or blood transfusion is anticipated during the study period (excluding temporary blood transfusion given in case of blood loss due to accident or surgery).
- Hypoalbuminemia (Serum albumin <2.5 g/dL) at Screening Visit.
- Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1.
- Life expectancy of <12 months.
- Cognitive or psychiatric condition rendering the patient unable to be cooperative with and complete study requirements.
- Hypersensitivity to any one of the investigational drugs or its excipients.
- Patients with very limited functional capacity for which a target Hb value of 12 g/dL may have a lower benefit/risk ratio.
- Immunosuppressive therapy (tacrolimus/cyclosporine, and other than corticosteroids for a chronic condition) within 12 weeks prior to Day 1.
- By history or current clinical evidence, patients with active acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection should be excluded. Routine screening for HBV, HCV, and human immunodeficiency virus (HIV) infection is not required in this protocol. Chronic HBV/HCV infection with liver function tests (LFT) >3 times of normal are excluded. Known HIV positive patients are excluded.
- History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than >3 alcoholic beverages per day.
- Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study.
- Females of childbearing potential or males who are unable/unwilling to take adequate contraceptive precautions defined by the protocol for the duration of the study and for at least 4 months for male subjects and 7 months for female patients after the end of the study. Females with a positive pregnancy test result within 24 hours prior to study entry, are otherwise known to be pregnant, plan to become pregnant in the next 12 months or are currently breastfeeding.
- Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Sponsor or clinical research organization (CRO) employees directly involved in the conduct of the study.
- History or clinical evidence of cardiovascular, hematologic, hepatic, or any physical conditions that, in the opinion of the Investigator, would compromise participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Taiwan
- Georgia
- Korea, Republic of
- Serbia
- Indonesia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Taiwan; Georgia; Korea, Republic of; Serbia; Indonesia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.