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

NCT ID: NCT02366325

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Chronic Renal Failure; Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EPO-018B 0.025 mg/kg

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

Group Type: EXPERIMENTAL

EPO-018B

Intervention Type: DRUG

EPO-018B 0.05 mg/kg

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

Group Type: EXPERIMENTAL

EPO-018B

Intervention Type: DRUG

EPO-018B 0.08 mg/kg

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

Group Type: EXPERIMENTAL

EPO-018B

Intervention Type: DRUG

Interventions

EPO-018B

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Changlin Mei

Role: STUDY_CHAIR

Changzheng Hospital

Locations

Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Changlin Mei

Role: CONTACT

Chlmei1954@126.com

021-81886191

Facility Contacts

Changlin Mei

Role: primary

Chlmei1954@126.com

021-81886191

Other Identifiers

HS-EPOP2a

Identifier Type: -

Identifier Source: org_study_id