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

NCT ID: NCT02586402

Last Updated: 2015-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegolsihematide

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).

Group Type: EXPERIMENTAL

pegol-Sihematide

Intervention Type: DRUG

Epoetin Alfa

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.

Group Type: ACTIVE_COMPARATOR

Epoetin Alfa

Intervention Type: DRUG

Interventions

pegol-Sihematide

Intervention Type: DRUG

Epoetin Alfa

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or females≥18 and≤70, Weight ≥ 45 kilograms (kg)

2. Participants with chronic renal failure on dialysis for ≥ 3 months prior to randomization.

3. On ESAs treatment for ≥8 weeks prior to randomization with stable doses and the average doses ≤ 10000 IU/week

4. Hemoglobin values of ≥ 10.0 and≤ 12.0 g/dL at Screening

5. Patients with a transferrin saturation≥ 20% and 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 randomization

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) greater than 30 mg/L within the 4 weeks prior to randomization

8. Uncontrolled or symptomatic secondary hyperparathyroidism(iPTH>800pg/ml)

9. Poorly controlled hypertension within 4 weeks prior to randomization

10. Chronic congestive heart failure (New York Heart Association Class Ⅲ or IV)

11. 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))

12. tumor malignancy

13. Expected survival less than 12 months

14. A scheduled kidney transplant

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 12 weeks prior to randomization

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Changli Mei

Role: STUDY_CHAIR

Changzheng Hospital

Locations

Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Changlin Mei

Role: CONTACT

Chlmei1954@126.com

021-81886191

Facility Contacts

Changlin Mei

Role: primary

Chlmei1954@126.com

021-81886191

Other Identifiers

HS-EPOP2c

Identifier Type: -

Identifier Source: org_study_id