Status:
COMPLETED
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
Lead Sponsor:
Vera Therapeutics, Inc.
Conditions:
BK Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04294472
Start Date
August 5 2020
End Date
February 10 2022
Last Update
June 7 2023
Active Locations (18)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0111
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Yale University
New Haven, Connecticut, United States, 06511
4
University of Kentucky
Lexington, Kentucky, United States, 40506