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

Hansoh Pharma

Status and phase: Unknown; Phase 2

Conditions: Anemia; Dialysis; Chronic Renal Failure

Treatments: Drug: pegol-Sihematide; Drug: Epoetin Alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02586402

HS-EPOP2c

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Pegolsihematide

Experimental group

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).

Treatment:

Drug: pegol-Sihematide

Epoetin Alfa

Active Comparator group

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.

Treatment:

Drug: Epoetin Alfa