Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis

NCT02586402 | Unknown Phase 2 DMC

• 1 other identifier: HS-EPOP2c
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of multiple intravenous doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on dialysis.

Conditions

Chronic Renal Failure; Anemia; Dialysis

Keywords

ESAs CKD

Outcome Measures

Primary Outcomes (1)

• Average reticulocytes and hemoglobin change from baseline

  Baseline to Week 16

Secondary Outcomes (4)

• Proportion of patients whose Hb within ±1.0 g/dL of baseline during Weeks 12 to 16

  week 12 to 16

• Average RBC, hematokrit and reticulocytes change from baseline

  Baseline to Week 16

• Proportion of patients whose Hb levels were maintained within 10 to 12.0g/dL during Weeks 12 to 16

  week 12 to 16

• Incidence of adverse events and serious adverse events

  Baseline to Week 16

Study Arms (2)

Pegolsihematide

EXPERIMENTAL

Participants received Pegolsihematide by intravenous injection once every 4 weeks ; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).

Drug: pegol-Sihematide

Epoetin Alfa

ACTIVE COMPARATOR

Epoetin Alfa administration 1 to 3 times per week. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

Drug: Epoetin Alfa

Interventions

pegol-Sihematide DRUG

Pegolsihematide

Epoetin Alfa DRUG

Epoetin Alfa

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females≥18 and≤70, Weight ≥ 45 kilograms (kg)
• Participants with chronic renal failure on dialysis for ≥ 3 months prior to randomization.
• On ESAs treatment for ≥8 weeks prior to randomization with stable doses and the average doses ≤ 10000 IU/week
• Hemoglobin values of ≥ 10.0 and≤ 12.0 g/dL at Screening
• Patients with a transferrin saturation≥ 20% and 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 randomization
• 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) greater than 30 mg/L within the 4 weeks prior to randomization
• Uncontrolled or symptomatic secondary hyperparathyroidism(iPTH\>800pg/ml)
• Poorly controlled hypertension within 4 weeks prior to randomization
• Chronic congestive heart failure (New York Heart Association Class Ⅲ or IV)
• significant symptom within 6 months prior to randomization (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, A positive test for HIV antibody or ALT\> 2 x upper limit of normal (ULN), AST\> 2 x upper limit of normal (ULN))
• tumor malignancy
• Expected survival less than 12 months
• A scheduled kidney transplant
• Major surgery (may Massive bleeding) during the study

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

Interventions

Epoetin Alfa

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

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Changli 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 26, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

CN (1)