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

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

Sponsors

Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
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.

Overall Status Unknown status
Start Date October 2015
Completion Date August 2016
Primary Completion Date August 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Average reticulocytes and hemoglobin change from baseline Baseline to Week 16
Secondary 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
Enrollment 60
Condition
Intervention

Intervention type: Drug

Intervention name: pegol-Sihematide

Arm group label: Pegolsihematide

Intervention type: Drug

Intervention name: Epoetin Alfa

Arm group label: Epoetin Alfa

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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Changli Mei Study Chair Changzheng Hospital
Overall Contact

Last name: Changlin Mei

Phone: 021-81886191

Email: [email protected]

Location
facility status contact Changzheng Hospital Changlin Mei 021-81886191 [email protected]
Location Countries

China

Verification Date

October 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Pegolsihematide

Arm group type: Experimental

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).

Arm group label: Epoetin Alfa

Arm group type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov