Overview

Phase III Clinical Study of Recombinant Erythropoiesis Stimulating Protein Injection (rESP) in the Treatment of Anemia in Hemodialysis Patients With Chronic Renal Failure

Status:
Recruiting
Trial end date:
2023-12-30
Target enrollment:
0
Participant gender:
All
Summary
To verify the efficacy of recombinant erythropoiesis stimulating protein injection (CHO cell) in hemodialysis patients with chronic renal failure anemia maintenance treatment is not inferior to yibio.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shenyang Sunshine Pharmaceutical Co., LTD.
Criteria
Inclusion Criteria:

- Volunteer as a subject must understand the study procedure and sign the informed
consent form;

- 18 years old ≤ age ≤ 75 years old when sign ICF, gender is not limited;

- Patients diagnosed with chronic renal failure anemia were receiving maintenance
hemodialysis for at least 3 months and 2-3 times a week; The dialysis frequency was
stable and there was no change in the dialysis plan throughout the study period;

- Before enrollment, patient being treated short-acting EPO stabilization therapy for at
least 12 weeks, the average concentration of hemoglobin in the screening period is in
the range of 100~120 g/L (including both ends), and the difference is less than 10g/L;

- Iron status and dialysis status were evaluated within 4 weeks before enrollment to
meet the following requirements:

Transferrin saturation (TSAT) ≥20% and serum ferritin (SF) ≥200 μg/L; Dialysis parameters:
urea clearance index spKt/V≥1.2;

- Subjects agree to use reliable contraceptives by themselves and their spouses from the
screening period to within 3 months after the end of the study;

Exclusion Criteria:

- Allergic to the investigational drug or any ingredient in the investigational drug or
has had a severe allergic reaction to the drug in the past;

- 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), blood systemic disease or
coagulopathy;

- Patients who have received or plan to have a kidney transplant during the study
period, or who plan to have other surgical procedures during the study period (mainly
major surgeries, except those with low blood loss that do not affect Hb
concentration);

- Patients with acute or chronic blood loss (such as upper gastrointestinal bleeding,
etc.) within 3 months prior to enrollment were excluded from the scope of hemorrhage
caused by minor surgeries such as temporary vascular access required by clinical
medical procedures;

- Patiernts who was suffering from malignant hypertension or poor control of blood
pressure (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg);

- The following conditions (including but not limited to) occurred in the laboratory
examination during the screening period, and the investigator judged that the
participants were not eligible for inclusion: a) Patients who were positive for HBsAg,
anti-HIV, anti-HCV, and Treponema pallidum antibodies; b) The aspartate
aminotransferase or alanine aminotransferase is greater than 3 times the upper limit
of normal; c) Serum albumin < 35g/L;

- Patiernts who was suffering from severe secondary hyperparathyroidism (sustained blood
iPTH/PTH >1000 ng/L);

- Patients with previous thromboembolic disease (excluding luminal infarction), history
of severe hematopoietic system, and high clotting tendency;

- Patiernts with severe cardiovascular and cerebrovascular disease, severe or unstable
coronary artery disease, heart failure (NYHA class III or IV), temporary vascular
access, or myocardial infarction or stroke within 3 months before enrollment;

- A history of malignant neoplasms, except for: basal cell or squamous cell carcinoma of
the skin determined to be cured or no recurrence within 5 years, with radical
excision, or carcinoma in situ at any site;

- The researchers identified those with severe infectious disease or chronic,
uncontrolled inflammation within the first four weeks of enrollment;

- All epilepsy or epilepsy history except of childhood febrile seizures, post-traumatic
or abstinence single seizures;

- Those who have received androgen therapy or who have received blood transfusion
therapy within the past 8 weeks before enrollment;

- Patients who had a pacemaker for more than 5 years; If no more than 5 years of cardiac
pacemaker working status assessment and test unqualified;

- 3 months as a subject to participate in other new drug clinical trials or to the group
when the withdrawal time is shorter than the five half-life of the test drug
(whichever is the longest of the two);

- Subjects were in the middle of pregnancy or lactation at the time of enrollment;

- Alcohol, drug or drug addicts;

- Other conditions that may not be suitable for the study as determined by the
investigator.