Safety & Efficacy of EPO-018B for the Treatment of Anemia in Participants With ERSD Receiving Maintenance Hemodialysis

Phase 2

• Conditions: Anemia; Chronic Renal Failure
• Interventions: Drug: EPO-018B

• Registration Number: NCT02366325
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Brief Summary

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 on hemodialysis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study Start: 2014-07
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-12
• Last Update Submitted: 2015-02-12
• Study First Posted: 2015-02-19
• Last Update Posted: 2015-02-19
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Males or females>=18 and≤65.
2. Receiving dialysis for at least 2 weeks before the first study dose.
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> 2 x upper limit of normal (ULN), AsT> 2 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. A scheduled kidney transplant
16. Major surgery (may Massive bleeding) during the study
17. Expected conception within 4 Weeks after the end of the Study Treatment
18. The subject has participated in other clinical trial within the 6 weeks prior to study drug administration
19. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EPO-018B 0.05 mg/kg	EPO-018B	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
EPO-018B 0.08 mg/kg	EPO-018B	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
EPO-018B 0.025 mg/kg	EPO-018B	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

Primary Outcome Measures

Name	Time	Method
Percentage of participants who achieved a target hemoglobin response during the study	Baseline to Week 24	A target hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline and a hemoglobin value ≥ 10.0 g/dL during the study

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events and serious adverse events	Baseline to Week 24
Average reticulocytes and hemoglobin change from baseline	Baseline to Week 24
Percentage of participants who response to study drug.	Baseline to Week 24	Hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline during the study.

Trial Locations

Locations (1)

Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China