Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03950687
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Shenyang Sunshine Pharmaceutical Co., LTD.

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

Condition or disease Intervention/treatment Phase
Chronic Renal Failure With Hemodialysis Drug: Recombinant Human Erythropoiesis Injection (CHO cell) Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell) Phase 2

Detailed Description:
In this phase 2, open label, active comparator parallel controlled study, patients were randomly assigned to three study groups: one active comparator control group (rHu EPO, maintaining the same dose and frequency administrated in the sceening period ), and two experimental groups (0.5μg/kg ,once a week; 1.0μg/kg , once every two weeks). All the patients were administered intravenously for 32 weeks and were evaluated the efficacy, safety and pharmacokinetic characteristics. During the whole study period, dosage adjustment was not allowed in the first 4 weeks, while in the remaining trial period dosage adjustment was allowed once every two weeks if necessary.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label, Active Comparator Parallel Controlled Phase 2 Clinical Study on Intravenous Administration of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis.
Estimated Study Start Date : May 25, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group A
intravenous administration, maintaining the same dose and frequency administrated in the sceening period, for 32 weeks
Drug: Recombinant Human Erythropoiesis Injection (CHO cell)
rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin
Other Name: rHuEPO

Experimental: Experimental group B
intravenous administration, 0.5μg/kg, once a week, for 32 weeks
Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
rESP is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites
Other Name: rESP

Experimental: Experimental group C

intravenous administration,

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

Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)
rESP is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites
Other Name: rESP




Primary Outcome Measures :
  1. Primary efficacy index :hemoglobin concentration [ Time Frame: 25th-32nd week ]
    the amount of change in mean Hb concentration compared with baseline Hb concentration during the evaluation period (25th-32nd week)


Secondary Outcome Measures :
  1. Secondary efficacy index:maintenance rate [ Time Frame: 25th-32nd week ]
    the proportion of subjects whose average Hb concentration remained within the target range during the evaluation period

  2. Secondary efficacy index :proportion of subjects [ Time Frame: for 32 weeks ]
    the proportion of subjects whose range of dose adjustments decreased or increased by 25% still did not reach 100-120 g/L (both ends)

  3. Secondary efficacy index: proportion of times [ Time Frame: 25th-32nd week ]
    the proportion of times the measured Hb concentration remains within the target range during the subject evaluation period

  4. Secondary efficacy index : average weekly dose [ Time Frame: 25th-32nd week ]
    the average weekly dose of the drug during the evaluation period (normalized by body weight)

  5. Secondary efficacy index: EPO dose conversion coefficient of rESP [ Time Frame: for 32 weeks ]
    the EPO dose conversion coefficient of rESP (the average weekly dose of rESP during the screening period) and the dose correlation

  6. Secondary efficacy index : mean reticulocyte count [ Time Frame: 25th-32nd week ]
    changes in mean values of reticulocyte compared to baseline values during the evaluation period.

  7. Secondary efficacy index : mean red blood cell count [ Time Frame: 25th-32nd week ]
    changes in mean values of red blood cell count compared to baseline values during the evaluation period

  8. Safety indicator: adverse events [ Time Frame: for 32 weeks ]
    the type, proportion and severity of adverse events

  9. Safety indicator: number of dose adjustments [ Time Frame: for 32 weeks ]
    the number of dose adjustments used by the subject during the treatment and evaluation period

  10. Safety indicator: the ratio of subjects who are adjusted [ Time Frame: for 32 weeks ]
    the ratio of subjects who are adjusted during the treatment and evaluation period

  11. Safety indicator: incidence of erythropoietin (EPO) antibodies and anti-rESP antibodies [ Time Frame: for 32 weeks ]
    incidence of erythropoietin (EPO) antibodies and anti-rESP antibodies

  12. Maximum Plasma Concentration (Cmax) [ Time Frame: for 32 weeks ]
    the Cmax of rESP in patients with long-term medication.

  13. Area Under the Curve (AUC) [ Time Frame: for 32 weeks ]
    the AUC of rESP in patients with long-term medication.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950687


Contacts
Layout table for location contacts
Contact: Xiangmei Chen, Medical PhD 13501261896 xmchen@126.com

Locations
Layout table for location information
China, Beijing
The general hospital of the people's liberation army Recruiting
Beijing, Beijing, China, 100000
Contact: Peipei Liang, PHD         
Principal Investigator: Xiangmei Chen, PhD         
Sponsors and Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.

Layout table for additonal information
Responsible Party: Shenyang Sunshine Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT03950687     History of Changes
Other Study ID Numbers: SYSS-SSS06-HD-II-01
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases