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

NCT02366325 | Unknown Phase 2 DMC

• 1 other identifier: HS-EPOP2a
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percentage of participants who response to study drug.

  Baseline to Week 24

• Average reticulocytes and hemoglobin change from baseline

  Baseline to Week 24

• Incidence of adverse events and serious adverse events

  Baseline to Week 24

Study Arms (3)

EPO-018B 0.025 mg/kg

EXPERIMENTAL

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

Drug: EPO-018B

EPO-018B 0.05 mg/kg

EXPERIMENTAL

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

Drug: EPO-018B

EPO-018B 0.08 mg/kg

EXPERIMENTAL

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

Drug: EPO-018B

Interventions

EPO-018B DRUG

EPO-018B 0.025 mg/kg; EPO-018B 0.05 mg/kg; EPO-018B 0.08 mg/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females\>=18 and≤65.
• Receiving dialysis for at least 2 weeks before the first study dose.
• Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose.
• Two hemoglobin values of ≥ 6.0 and \< 10.0 g/dL at Screening
• Patients with a transferrin saturation ≥ 20% or a ferritin≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
• Signed informed consent.

You may not qualify if:

• Pregnant or lactating females.
• Red blood cell transfusion within 3 months prior to study drug administration.
• Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
• Hemolytic syndromes or coagulation disorder.
• Hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, , hemoglobinopathy, pure red cell aplasia).
• Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis,systemic lupus erythematosus, etc.).
• C reactive Protein (CRP) level greater than 30 mg/L within the 4 weeks prior to study drug administration.
• Uncontrolled or symptomatic secondary hyperparathyroidism，iPTH\>500pg/ml.
• 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).
• Chronic congestive heart failure (New York Heart Association Class IV).
• 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.).
• A positive test for HIV antibody.
• Tumor malignancy
• Expected survival less than 12 months,
• A scheduled kidney transplant

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Changlin Mei

  Changzheng Hospital

  STUDY CHAIR

Central Study Contacts

Changlin Mei

CONTACT

021-81886191; Chlmei1954@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 19, 2015
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 19, 2015

Record last verified: 2014-06

Locations

CN (1)