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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anemia; Dialysis; Chronic Renal Failure
• Intervention / Treatment: Drug: Epoetin Alfa; Drug: pegol-Sihematide

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Recruiting
      • Changzheng hospital
      • Contact: Changlin Mei; Phone Number: 021-81886191; Email: Chlmei1954@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: pegol-Sihematide
Active Comparator: 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.	Drug: Epoetin Alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average reticulocytes and hemoglobin change from baseline	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Changli Mei, Changzheng hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Estimate): October 26, 2015
• Last Update Submitted That Met QC Criteria: October 23, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: ESAs CKD
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: HS-EPOP2c