Clinical trial NCT02586402: Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Renal Failure
Anemia
Dialysis
Keywords: ESAs CKD
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Average reticulocytes and hemoglobin change from baseline
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Proportion of patients whose Hb within ±1.0 g/dL of baseline during Weeks 12 to 16
timeFrame: week 12 to 16
measure: Average RBC, hematokrit and reticulocytes change from baseline
timeFrame: Baseline to Week 16
measure: Proportion of patients whose Hb levels were maintained within 10 to 12.0g/dL during Weeks 12 to 16
timeFrame: week 12 to 16
measure: Incidence of adverse events and serious adverse events
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Changzheng Hospital
name: Changli Mei
role: STUDY_CHAIR
References: