A Phase 2 Clinical Study of Pegerythropoietin Injection (RD01) for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter randomized, single blind, active comparator controlled phase 2 study which is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure patients with hemodialysis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients with chronic renal failure who are undergoing maintenance hemodialysis for at least 12 weeks;

• 18 ≤ age ≤ 75 years of age, male or female;

• Patients who have received short-acting EPO treatment and meets the treatment standard (hemoglobin 100 ~ 120 g / L). The mean Hb value in the screening period (at least two weeks apart ) is within the range of 100 ~ 120 g / L (both ends). The difference is less than 10g / L;

• Evaluation of iron status during the screening period, transferrin saturation (TSAT) ≥20% or serum ferritin (SF) ≥200 μg / L;

• Evaluation of dialysis adequacy during the screening period, with SpKt / V≥1.2 or URR≥65%;

• Subjects agree to use reliable contraceptives from the screening period to within 6 months after the last medication

• Sign the informed consent.

Exclusion Criteria:

• Patients who have received or plan to have a kidney transplant during the study period

• Except of renal anemia, there are other diseases that cause chronic anemia (such as sickle cell anemia, myelodysplastic syndrome, hematological malignancies, myeloma, hemolytic anemia, pure red blood cell aplastic anemia)

• Patients with acute or chronic blood loss (such as upper gastrointestinal bleeding) in the past 3 months or patients who have undergone surgery with extensive bleeding, or patients who plan to undergo surgery during the study period

• Patients with coagulation dysfunction (time to activate partial thromboplastin> 1.5 times the upper limit of normal value)

• The following circumstances (including but not limited to) during the screening, investigators evaluated that it is not suitable for enrollment:

1. Abnormal liver function (aspartate aminotransferase or alanine aminotransferase is more than 3 times the upper limit of normal value);

2. Patients who were positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antigen (HBeAg), HIV antibody (HIV-Ab), hepatitis C virus antibody (HCV-Ab) or Treponema pallidum antibody;

• Patients with severe secondary hyperparathyroidism (iPTH> 1000 ng / L);

• Patients with severe hypertension and poor control of blood pressure (systolic blood pressure> 180 mmHg or diastolic blood pressure> 100 mmHg)

• Patients with severe thromboembolic disease

• People with severe cardio-cerebral vascular disease (excluding luminal infarction), severe or unstable coronary artery disease, heart failure (NYHA III or IV) or myocardial infarction or stroke within 3 months

• Patients with malignant tumors (excluding non-melanoma skin cancer or resected cancer in situ)

• People with a history of severe allergies (including drug allergies), allergies to erythropoietin, or allergic to any component of the test drug (such as human serum albumin)

• People with severe infection who are receiving systemic antibiotics

• Patients who have received androgen therapy or blood transfusion therapy within the last 8 weeks;

• Participated in other new drug clinical trials as a subject within 3 months or the withdrawal time was shorter than the 5 half-life of the test drug at the time of enrollment (whichever is the longest);

• Patients with a history of seizures

• Pregnant and lactating women

• Alcohol, drug or drug addicts

• Other situations that the researcher believes may affect validity judgment or are not suitable for participation.