Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome (PRIME)
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ClinicalTrials.gov Identifier: NCT05914155 |
Recruitment Status :
Recruiting
First Posted : June 22, 2023
Last Update Posted : July 21, 2023
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Sponsor:
Shoichi Maruyama MD PhD
Information provided by (Responsible Party):
Shoichi Maruyama MD PhD, Nagoya University
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 13, 2023 | ||||||||
First Posted Date ICMJE | June 22, 2023 | ||||||||
Last Update Posted Date | July 21, 2023 | ||||||||
Actual Study Start Date ICMJE | June 24, 2023 | ||||||||
Estimated Primary Completion Date | December 31, 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Percentage of patients achieving ICR I [ Time Frame: up to 26 weeks ] Achieving ICR I is defined as "Urine protein-creatinine ratio < 1.0 g/gCr".
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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 | Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome | ||||||||
Official Title ICMJE | The Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rituximab (Genetical Recombination) for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome (PRIME Study) | ||||||||
Brief Summary | To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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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 |
88 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2026 | ||||||||
Estimated Primary Completion Date | December 31, 2026 (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 | 15 Years and older (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Japan | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05914155 | ||||||||
Other Study ID Numbers ICMJE | CAMCR-020 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Shoichi Maruyama MD PhD, Nagoya University | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Shoichi Maruyama MD PhD | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Nagoya University | ||||||||
Verification Date | July 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |