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

NCT05211167 | Unknown Phase 3

• 1 other identifier: SYSS-SSS06-HD-III-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Failure, Chronic; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• hemoglobin concentration

  the amount of change in mean Hb concentration compared with baseline Hb concentration during the evaluation period

  25th-32nd week

Secondary Outcomes (13)

• maintenance rate

  25th-32nd week

• proportion of subjects

  for 32 weeks

• proportion of times

  25th-32nd week

• average weekly dose

  25th-32nd week

• average hemoglobin concentration

  25th-32nd week

Study Arms (2)

Group A

ACTIVE COMPARATOR

Intravenous administration, maintaining the same dose and frequency administrated in the sceening period, for 32 weeks

Drug: Human Erythropoiesis Injection (CHO cell)

Group B

EXPERIMENTAL

Intravenous administration,50μg, once every two weeks, for 32 weeks

Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)

Interventions

Human Erythropoiesis Injection (CHO cell) DRUG

Human Erythropoiesis Injection (CHO cell) is a recombinant human erythropoietin with the same biological effects as natural erythropoietin

Group A

Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell) DRUG

rESP is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites

Also known as: rESP

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 200443, China

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• XiangMei Chen, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Tong, MD

CONTACT

021-60970099; tonggang@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: July 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

CN (1)