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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02586402
• Other study ID #: HS-EPOP2c
• Status: Recruiting
• Phase: Phase 2
• First received: October 23, 2015
• Last updated: October 23, 2015
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2015
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Changlin Mei
• Phone: 021-81886191
• Email: Chlmei1954[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ? 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chronic Renal Failure
• Dialysis
• Kidney Failure, Chronic

Intervention

Drug:
• pegol-Sihematide

• Epoetin Alfa

Locations

Country	Name	City	State
China	Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average reticulocytes and hemoglobin change from baseline		Baseline to Week 16	No
Secondary	Proportion of patients whose Hb within ±1.0 g/dL of baseline during Weeks 12 to 16		week 12 to 16	No
Secondary	Average RBC, hematokrit and reticulocytes change from baseline		Baseline to Week 16	No
Secondary	Proportion of patients whose Hb levels were maintained within 10 to 12.0g/dL during Weeks 12 to 16		week 12 to 16	No
Secondary	Incidence of adverse events and serious adverse events		Baseline to Week 16	Yes