Clinical trial NCT02403362: Safety & Efficacy of EPO-018B for the Treatment of Anemia in Participants With Chronic Kidney Diseases Not on Dialysis
Official title: A Phase 2, Open-Label, Multi-Center , Dose-Ranging Study of the Safety and Efficacy of Pegol-Sihematide (EPO-018B) for the Treatment of Anemia in Patients With Chronic Kidney Disease Not Requiring Dialysis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Renal Failure
Chronic Kidney Disease
Anemia
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
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 not on dialysis


Eligibility criteria: 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.

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 change from baseline
timeFrame: Baseline to Week 24
measure: Average hemoglobin change from baseline
timeFrame: Baseline to Week 24
measure: Incidence of adverse events
timeFrame: Baseline to Week 24
measure: Incidence of serious adverse events
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu
role: STUDY_CHAIR
References: