Condition or disease | Intervention/treatment | Phase |
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Chronic Renal Failure With Hemodialysis | Drug: Recombinant Human Erythropoiesis Injection (CHO cell) Drug: Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell) | Phase 2 |
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. |
Actual Study Start Date : | June 24, 2019 |
Estimated Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | December 30, 2020 |
Arm | Intervention/treatment |
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Active Comparator: Control group A
intravenous administration, maintaining the same dose and frequency administrated in the sceening period, for 32 weeks
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Drug: Recombinant Human Erythropoiesis Injection (CHO cell)
rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin
Other Name: rHuEPO
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Experimental: Experimental group B
intravenous administration, 0.5μg/kg, once a week, for 32 weeks
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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
|
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following circumstances (including but not limited to), the investigators evaluated that it is not suitable for enrollment:
Contact: Xiangmei Chen, Medical PhD | 13501261896 | xmchen@126.com |
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 |
Tracking Information | |||||
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First Submitted Date ICMJE | May 10, 2019 | ||||
First Posted Date ICMJE | May 15, 2019 | ||||
Last Update Posted Date | March 9, 2020 | ||||
Actual Study Start Date ICMJE | June 24, 2019 | ||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis | ||||
Official Title ICMJE | 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. | ||||
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 | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Renal Failure With Hemodialysis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
150 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 30, 2020 | ||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03950687 | ||||
Other Study ID Numbers ICMJE | SYSS-SSS06-HD-II-01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Shenyang Sunshine Pharmaceutical Co., LTD. | ||||
Study Sponsor ICMJE | Shenyang Sunshine Pharmaceutical Co., LTD. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Shenyang Sunshine Pharmaceutical Co., LTD. | ||||
Verification Date | March 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |