At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
MAU868 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating MAU868 and Placebo for BK Virus Infection. Completed, enrolled 30 participants across 18 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBK Virus Infection
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 2020
Enrollment StartAug 2020
Primary CompletionFeb 2022
TodayJul 2026
First PostedMar 4, 2020
Enrollment StartAug 5, 2020
Primary CompletionFeb 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.3 years ago
Interventions
MAU868drug
MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Placeboother
250 mL D5W placebo IV to be labeled to match that of MAU868