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

Vera Therapeutics, Inc.30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

BK Virus Infection

Interventions

MAU868DRUG

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

PlaceboOTHER

250 mL D5W placebo IV to be labeled to match that of MAU868

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Study Week 1 - Study Week 36

Data from ClinicalTrials.gov

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