BK Virus Infection Clinical Trial
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)
Verified date | February 2023 |
Source | Vera Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 10, 2022 |
Est. primary completion date | February 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal | Montréal | Quebec |
Canada | The Research Institute of the McGill University Health Centre | Montréal | Quebec |
Canada | University Health Network | Toronto | Ontario |
United States | The Johns Hopkins University | Baltimore | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
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 Kentucky | Lexington | Kentucky |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania |
United States | Washington University | Saint Louis | Missouri |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Vera Therapeutics, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Study Week 1 - Study Week 36 | |
Primary | 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. | Study Week 1 - Study Week 36 |
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