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

Completed · Phase 2 · Has a placebo group

Conditions studied: BK Virus Infection

In brief

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.

Key facts

Study ID

NCT04294472

Run by

Vera Therapeutics, Inc.

People needed

30

Starts

2020-08-05

Expected to finish

2022-02-10

Last updated by the study team

2023-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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