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

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);

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.

What this study is about