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

This is an interventional treatment trial for Patient of Anemia in Chronic Renal Failure With Hemodialysis Read More

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.