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

NCT03950687 | Unknown Phase 2

• 1 other identifier: SYSS-SSS06-HD-II-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Renal Failure With Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Primary efficacy index :hemoglobin concentration

  the amount of change in mean Hb concentration compared with baseline Hb concentration during the evaluation period (25th-32nd week)

  25th-32nd week

Secondary Outcomes (13)

• Secondary efficacy index:maintenance rate

  25th-32nd week

• Secondary efficacy index :proportion of subjects

  for 32 weeks

• Secondary efficacy index: proportion of times

  25th-32nd week

• Secondary efficacy index : average weekly dose

  25th-32nd week

• Secondary efficacy index: EPO dose conversion coefficient of rESP

  for 32 weeks

Study Arms (3)

Control group A

ACTIVE COMPARATOR

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

Drug: Recombinant Human Erythropoiesis Injection (CHO cell)

Experimental group B

EXPERIMENTAL

intravenous administration, 0.5μg/kg, once a week, for 32 weeks

Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)

Experimental group C

EXPERIMENTAL

intravenous administration, 1μg/kg, once every two weeks, for 32 weeks

Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)

Interventions

Recombinant Human Erythropoiesis Injection (CHO cell) DRUG

rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin

Also known as: rHuEPO

Control 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

Experimental group B; Experimental group C

Eligibility Criteria

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

You may qualify if:

• Patients with chronic renal failure are undergoing maintenance hemodialysis for at least 3 months and at least 2 times a week;
• years old ≤ age ≤ 75 years old, gender is not limited;
• 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;
• Evaluation of iron status within 4 weeks, transferrin saturation (TSAT) ≥ 20% and serum ferritin (SF) ≥ 200 μg / L;
• 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;
• Volunteer as a subject and sign an informed consent form.

You may not qualify if:

• 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;
• 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;
• There are acute or chronic blood loss within the past 3 months, such as gastrointestinal bleeding;
• 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;
• Patiernts who was suffering from severe secondary hyperparathyroidism (sustained blood iPTH/PTH \>1000 ng/L);
• Patiernts who was suffering from malignant hypertension or poor control of blood pressure (systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg);
• 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;
• Patients with malignant tumors (excluding non-melanoma skin cancer or excised carcinoma in situ);
• 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);
• The infection is being treated with systemic antibiotics;
• Those who have received androgen therapy or who have received blood transfusion therapy within the past 8 weeks;

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

The general hospital of the people's liberation army

Beijing, Beijing Municipality, 100000, China

RECRUITING

Central Study Contacts

Xiangmei Chen, Medical PhD

CONTACT

13501261896; xmchen@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 15, 2019
• Study Start: June 24, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)