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

Primary Purpose

Chronic Renal Failure, Anemia, Dialysis

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

pegol-Sihematide

Epoetin Alfa

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring ESAs CKD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
expected conception within 4 Weeks after the end of the Study Treatment
The subject has participated in other clinical trial within the 12 weeks prior to randomization
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

Sites / Locations

Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pegolsihematide

Epoetin Alfa

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Average reticulocytes and hemoglobin change from baseline

Secondary Outcome Measures

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

Average RBC, hematokrit and reticulocytes change from baseline

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

Incidence of adverse events and serious adverse events

Full Information

NCT ID

NCT02586402

First Posted

October 23, 2015

Last Updated

October 23, 2015

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02586402

Brief Title

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

Official Title

A Phase 2, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Pegolsihematide for the Correction of Anemia in Patients With CRF Undergoing Dialysis and Previously Treated With ESAs

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure, Anemia, Dialysis

Keywords

ESAs CKD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pegolsihematide

Arm Type

Experimental

Arm Description

Arm Title

Epoetin Alfa

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

pegol-Sihematide

Intervention Type

Drug

Intervention Name(s)

Epoetin Alfa

Primary Outcome Measure Information:

Title

Average reticulocytes and hemoglobin change from baseline

Time Frame

Baseline to Week 16

Secondary Outcome Measure Information:

Title

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

Time Frame

week 12 to 16

Title

Average RBC, hematokrit and reticulocytes change from baseline

Time Frame

Baseline to Week 16

Title

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

Time Frame

week 12 to 16

Title

Incidence of adverse events and serious adverse events

Time Frame

Baseline to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 expected conception within 4 Weeks after the end of the Study Treatment The subject has participated in other clinical trial within the 12 weeks prior to randomization 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Changlin Mei

Phone

021-81886191

Chlmei1954@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Changli Mei

Organizational Affiliation

Changzheng Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Changzheng Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Changlin Mei

Phone

021-81886191

Chlmei1954@126.com

12. IPD Sharing Statement

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

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