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

Anemia Clinical Trial

Official title:

A Phase 2, Open-Label, Multi-Center , Dose-Finding Study of the Safety and Efficacy of Pegol-Sihematide (EPO-018B) for the Treatment of Anemia in Patients With End-Stage Renal Disease Receiving Maintenance Hemodialysis (HD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02366325
• Other study ID #: HS-EPOP2a
• Status: Recruiting
• Phase: Phase 2
• First received: February 12, 2015
• Last updated: February 12, 2015
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2014
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Changlin Mei
• Phone: 021-81886191
• Email: Chlmei1954[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

Drug:
• EPO-018B

Locations

Country	Name	City	State
China	Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who achieved a target hemoglobin response during the study	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	Baseline to Week 24	No
Secondary	Percentage of participants who response to study drug.	Hemoglobin response is defined as a hemoglobin increase of = 1.0 gram per deciliter (g/dL) from baseline during the study.	Baseline to Week 24	No
Secondary	Average reticulocytes and hemoglobin change from baseline		Baseline to Week 24	No
Secondary	Incidence of adverse events and serious adverse events		Baseline to Week 24	Yes