Overview

Study of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis

Status:
Recruiting
Trial end date:
2020-12-30
Target enrollment:
0
Participant gender:
All
Summary
A phase 2, randomized, open label, active comparator parallel controlled study to explore the dosage regiment of rESP, and evaluate its efficacy, safety and pharmacokinetic characteristics in the treatment of anemia in chronic renal failure patients with hemodialysis
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shenyang Sunshine Pharmaceutical Co., LTD.
Criteria
Inclusion Criteria:

1. Patients with chronic renal failure are undergoing maintenance hemodialysis for at
least 3 months and at least 2 times a week;

2. 18 years old ≤ age ≤ 75 years old, gender is not limited;

3. Being treated with rHuEPO 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;

4. Evaluation of iron status within 4 weeks, transferrin saturation (TSAT) ≥ 20% and
serum ferritin (SF) ≥ 200 μg / L;

5. 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;

6. Volunteer as a subject and sign an informed consent form.

Exclusion Criteria:

1. Patients who have received or plan to undergo a kidney transplant during the study
period, or who plan to undergo other surgery during the study;

2. 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;

3. There are acute or chronic blood loss within the past 3 months, such as
gastrointestinal bleeding;

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

- Kt/V<1.2 or URR<65%;

- Abnormal liver function (the aspartate aminotransferase or alanine
aminotransferase is greater than 3 times the upper limit of normal);

- Patients who were positive for anti-HIV, anti-HCV, and Treponema pallidum
antibodies;

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

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

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

8. 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;

9. Patients with malignant tumors (excluding non-melanoma skin cancer or excised
carcinoma in situ);

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

11. The infection is being treated with systemic antibiotics;

12. Those who have received androgen therapy or who have received blood transfusion
therapy within the past 8 weeks;

13. 5 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);

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

15. Pregnant women and lactating women;

16. Alcohol, drug or drug addicts;

17. Other factors investigators believe that they may affect the efficacy judgment or is
not suitable for participation.