Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04294472 | A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients | PHASE2 | COMPLETED | 30 | — | — | Aug 5, 2020 | Feb 10, 2022 | Jun 7, 2023 | 18 | United States, Canada |
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses |
| Cohort 2 | EXPERIMENTAL | Cohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses |
| Cohort 3 | EXPERIMENTAL | Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses |
| Placebo Cohort 1, 2, 3 | PLACEBO_COMPARATOR | 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses |
| Name | Type | Description |
|---|---|---|
| MAU868 | DRUG | 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 |
| Placebo | OTHER | 250 mL D5W placebo IV to be labeled to match that of MAU868 |
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 ...