A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients

BK Virus Infection Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294472
• Other study ID #: MAU868-201
• Status: Completed
• Phase: Phase 2
• Start date: August 5, 2020
• Est. completion date: February 10, 2022

Study information

• Verified date: February 2023
• Source: Vera Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• BK Virus Infection
• Viremia

Intervention

Drug:
• MAU868
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

Other:
• Placebo
250 mL D5W placebo IV to be labeled to match that of MAU868

Locations

Country	Name	City	State
Canada	Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal	Montréal	Quebec
Canada	The Research Institute of the McGill University Health Centre	Montréal	Quebec
Canada	University Health Network	Toronto	Ontario
United States	The Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Renal Disease Research Institute, LLC	Dallas	Texas
United States	The University of Texas Southwester Medical Center	Dallas	Texas
United States	Houston Methodist Research Institute	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Vera Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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