- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04294472
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
June 5, 2023 updated by: Vera Therapeutics, Inc.
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Efficacy of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (Neutra4)
This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network
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Quebec
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Montréal, Quebec, Canada, H1T 2M4
- Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal
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Montréal, Quebec, Canada, H4A 3J1
- The Research Institute of the McGill University Health Centre
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Alabama
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Birmingham, Alabama, United States, 35294-0111
- University of Alabama at Birmingham
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale University
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Kentucky
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Lexington, Kentucky, United States, 40506
- University of Kentucky
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Maryland
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Baltimore, Maryland, United States, 21205
- The Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, United States, 02241
- Massachusetts General Hospital
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Missouri
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Saint Louis, Missouri, United States, 63130
- Washington University
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center (UPMC)
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, United States, 75235
- Renal Disease Research Institute, LLC
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Dallas, Texas, United States, 75390
- The University of Texas Southwester Medical Center
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Houston, Texas, United States, 77030
- Houston Methodist Research Institute
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Be a male or female 18 years of age or older.
- Recipient of a kidney (or kidney-pancreas) transplant within the year prior to enrollment
- Documented BKV viremia based on local or central laboratory testing within 10 days
Exclusion Criteria:
- A BKV plasma viral load which has exceeded 10^3 copies/mL for >4 months.
- A BKV plasma viral load of ≥ 10^7 copies/mL.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cohort 1
Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
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MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
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Experimental: Cohort 2
Cohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses
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MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
|
Experimental: Cohort 3
Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
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MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
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Placebo Comparator: Placebo Cohort 1, 2, 3
5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
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250 mL D5W placebo IV to be labeled to match that of MAU868
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log
Time Frame: Study Week 1 - Study Week 36
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The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
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Study Week 1 - Study Week 36
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Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)
Time Frame: Study Week 1 - Study Week 36
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The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
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Study Week 1 - Study Week 36
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2020
Primary Completion (Actual)
February 10, 2022
Study Completion (Actual)
February 10, 2022
Study Registration Dates
First Submitted
February 26, 2020
First Submitted That Met QC Criteria
March 2, 2020
First Posted (Actual)
March 4, 2020
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
June 5, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAU868-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on BK Virus Infection
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AlloVirWithdrawnBK Virus InfectionUnited States
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King Chulalongkorn Memorial HospitalRecruitingBK Virus Infection | Kidney Transplant Infection | BK Virus NephropathyThailand
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University Hospital, Strasbourg, FranceRecruiting
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SL VAXiGENSL BIGENUnknownBK Virus Infection | Cytomegalovirus Infections | Preventation of Cytomegalovirus Reactivation | Preventation of BK Virus ReactivationKorea, Republic of
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King Chulalongkorn Memorial HospitalRecruitingBK Virus Infection | Kidney Transplant InfectionThailand
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Dana-Farber Cancer InstituteActive, not recruiting
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Children's Hospital of PhiladelphiaRecruitingBK PolyomavirusUnited States
-
University Hospital, Strasbourg, FranceNot yet recruitingBK Virus InfectionFrance
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University of California, San FranciscoCompletedBK Virus InfectionUnited States
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Loma Linda UniversityWithdrawnBK Virus Infection | BK Virus NephropathyUnited States
Clinical Trials on MAU868
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Novartis PharmaceuticalsWithdrawn