Clinical trial NCT04294472: A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: BK Virus Infection
Lead sponsor: Vera Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log
timeFrame: Study Week 1 - Study Week 36
measure: Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)
timeFrame: Study Week 1 - Study Week 36
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Renal Disease Research Institute, LLC
state: Texas
city: Dallas
country: United States
facility: The University of Texas Southwester Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montréal
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal
state: Quebec
city: Montréal
country: Canada
facility: The Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
References: