Clinical trial NCT02366325: Safety & Efficacy of EPO-018B for the Treatment of Anemia in Participants With ERSD Receiving Maintenance Hemodialysis
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Renal Failure
Anemia
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of participants who achieved a target hemoglobin response during the study
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Percentage of participants who response to study drug.
timeFrame: Baseline to Week 24
measure: Average reticulocytes and hemoglobin change from baseline
timeFrame: Baseline to Week 24
measure: Incidence of adverse events and serious adverse events
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Changzheng Hospital
name: Changlin Mei
role: STUDY_CHAIR
References: