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

Status

Completed

Conditions

Intervention / Treatment

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

    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal
      • Montréal, Quebec, Canada, H4A 3J1
        • The Research Institute of the McGill University Health Centre
    • Alabama
      • Birmingham, Alabama, United States, 35294-0111
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • The Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02241
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center (UPMC)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75235
        • Renal Disease Research Institute, LLC
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwester Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

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
Experimental: Cohort 1
Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
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 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
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
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
Placebo Comparator: Placebo Cohort 1, 2, 3
5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
250 mL D5W placebo IV to be labeled to match that of MAU868

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
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)
Time Frame: Study Week 1 - Study Week 36
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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.

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