A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
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)
1 other identifier
interventional
30
2 countries
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2020
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2020
CompletedStudy Start
First participant enrolled
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2022
CompletedResults Posted
Study results publicly available
May 24, 2023
CompletedJune 7, 2023
February 1, 2023
1.5 years
February 26, 2020
February 9, 2023
June 5, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Study Week 1 - Study Week 36
Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Study Week 1 - Study Week 36
Study Arms (4)
Cohort 1
EXPERIMENTALCohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
Cohort 2
EXPERIMENTALCohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses
Cohort 3
EXPERIMENTALCohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
Placebo Cohort 1, 2, 3
PLACEBO COMPARATOR5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0111, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Yale University
New Haven, Connecticut, 06511, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
The Johns Hopkins University
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02241, United States
Washington University
St Louis, Missouri, 63130, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Renal Disease Research Institute, LLC
Dallas, Texas, 75235, United States
The University of Texas Southwester Medical Center
Dallas, Texas, 75390, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98195, United States
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4, Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Related Publications (2)
Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
PMID: 39382091DERIVEDHelle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.
PMID: 39352862DERIVED
Results Point of Contact
- Title
- Isabel Gorham, Director of Clinical Operations
- Organization
- Vera Therapeutics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2020
First Posted
March 4, 2020
Study Start
August 5, 2020
Primary Completion
February 10, 2022
Study Completion
February 10, 2022
Last Updated
June 7, 2023
Results First Posted
May 24, 2023
Record last verified: 2023-02