Safety & Efficacy of EPO-018B for the Treatment of Anemia in Participants With Chronic Kidney Diseases Not on Dialysis

Hansoh Pharma

Status and phase: Unknown; Phase 2

Conditions: Anemia; Chronic Kidney Disease; Chronic Renal Failure

Treatments: Drug: EPO-018B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02403362

HS-EPOP2b

Details and patient eligibility

About

The purpose of this study is to evaluate the safety,efficacy， pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic kidney disease (CKD) Who are not on dialysis

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females ≥18 and≤70.
2. Chronic renal diseases stage 3 or 4 (estimated Glomerular Filtration Rate (eGFR) between 15 and 60 ml/min per 1.73 m2 using the CKD-EPI equation) and no expected need for dialysis during the study.
3. Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose.
4. Two hemoglobin values of ≥ 6.0 and < 10.0 g/dL at Screening
5. Patients with a transferrin saturation ≥ 20% or a ferritin ≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
6. Signed informed consent.

Exclusion criteria

1. Pregnant or lactating females.
2. Red blood cell transfusion within 3 months prior to study drug administration.
3. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products .
4. Hemolytic syndromes or coagulation disorder.
5. Hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, hemoglobinopathy, pure red cell aplasia).
6. Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.).
7. C reactive Protein (CRP)level greater than 30 mg/L within the 4 weeks prior to study drug administration.
8. Uncontrolled or symptomatic secondary hyperparathyroidism(iPTH>500pg/ml).
9. Poorly controlled hypertension within 2 weeks prior to study drug administration, per investigator's clinical judgment (e.g. systolic ≥ 160mm Hg, diastolic ≥ 100 mm Hg)
10. Chronic congestive heart failure (New York Heart Association Class IV).
11. Significant symptom within 6 months prior to study drug administration (e.g. myocardial infarction, serious or precarious coronary artery disease,stroke, respiratory disease, autoimmune disease, neuropathy, phrenopathy, hepatopathy including Active hepatitis B, Active hepatitis C, or ALT> 3 x upper limit of normal (ULN), AST> 3 x upper limit of normal (ULN), etc.).
12. A positive test for HIV antibody.
13. Tumor malignancy.
14. Expected survival less than 12 months.
15. Major surgery (may Massive bleeding) during the study.
16. Expected conception within 4 Weeks after the end of the Study Treatment.
17. The subject has participated in other clinical trial within the 6 weeks prior to study drug administration.
18. Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

EPO-018B 0.025 mg/kg

Experimental group

Description:

EPO-018B starting dose of 0.025 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses

Treatment:

Drug: EPO-018B

EPO-018B 0.05 mg/kg

Experimental group

Description:

EPO-018B starting dose of 0.05 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses

Treatment:

Drug: EPO-018B

EPO-018B 0.08 mg/kg

Experimental group

Description:

EPO-018B starting dose of 0.08 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses

Treatment:

Drug: EPO-018B