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

Phase 2

Completed

• Conditions: BK Virus Infection
• Interventions: Drug: MAU868; Other: Placebo

• Registration Number: NCT04294472
• Lead Sponsor: Vera Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Study Start: 2020-08-05
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Status Verified: 2023-02
• Results First Submitted: 2023-02-09
• Results First Submitted QC: 2023-05-01
• Results First Posted: 2023-05-24
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	MAU868	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
Cohort 1	MAU868	Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
Placebo Cohort 1, 2, 3	Placebo	5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
Cohort 3	MAU868	Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses

Primary Outcome Measures

Name	Time	Method
Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log	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.
Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)	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.

Trial Locations

Locations (18)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

The Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

University of Pittsburgh Medical Center (UPMC); 🇺🇸 Pittsburgh, Pennsylvania, United States

Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal; 🇨🇦 Montréal, Quebec, Canada

Renal Disease Research Institute, LLC; 🇺🇸 Dallas, Texas, United States

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States

University Health Network; 🇨🇦 Toronto, Ontario, Canada

The Research Institute of the McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

The University of Texas Southwester Medical Center; 🇺🇸 Dallas, Texas, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States