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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Renal Failure, Anemia, Dialysis

Intervention / Treatment
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* Drug: pegol-Sihematide
* Drug: Epoetin Alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegolsihematide<br>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<br> <br> |
| Active Comparator: Epoetin Alfa<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESAs CKD