BK Virus Infection
Conditions
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.
Interventions
DRUGMAU868
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
OTHERPlacebo
250 mL D5W placebo IV to be labeled to match that of MAU868
Sponsors
Vera Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log | Study Week 1 - Study Week 36 | The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time. |
| Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ) | Study Week 1 - Study Week 36 | The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses | 8 |
| Active Arm (Cohort 1) MAU868 1350 mg every 28 days for a total of 4 doses | 10 |
| Active Arm (Cohort 2) MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses | 10 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Randomized but not treated | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 6 Participants | 6 Participants | 8 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 12.97 | 52.5 years STANDARD_DEVIATION 16.85 | 60.1 years STANDARD_DEVIATION 13.52 | 56.2 years STANDARD_DEVIATION 8.5 |
| Baseline Plasma Viral Load (copies/mL) based on central lab | 129239.3 copies/mL STANDARD_DEVIATION 350731.32 | 315100.0 copies/mL STANDARD_DEVIATION 620601.58 | 85100.0 copies/mL STANDARD_DEVIATION 152159.91 | 24690.0 copies/mL STANDARD_DEVIATION 36203.73 |
| Duration of BK Viremia (days) | 51.9 Days STANDARD_DEVIATION 29.99 | 58.4 Days STANDARD_DEVIATION 23.11 | 56.6 Days STANDARD_DEVIATION 39.33 | 41.9 Days STANDARD_DEVIATION 23.74 |
| eGFR (CK-EPI)(mL/min/ 1.73m^2) | 54.6 mL/min/ 1.73m^2 STANDARD_DEVIATION 18.66 | 59.5 mL/min/ 1.73m^2 STANDARD_DEVIATION 21.23 | 54.1 mL/min/ 1.73m^2 STANDARD_DEVIATION 22.93 | 51.1 mL/min/ 1.73m^2 STANDARD_DEVIATION 11.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 0 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 8 Participants | 7 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 4 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment Canada | 3 Participants | 0 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 25 Participants | 8 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 23 Participants | 5 Participants | 9 Participants | 9 Participants |
| Time from Kidney Transplant (days) | 163.9 Days STANDARD_DEVIATION 87.21 | 174.6 Days STANDARD_DEVIATION 82.57 | 175.6 Days STANDARD_DEVIATION 93.53 | 143.5 Days STANDARD_DEVIATION 89.72 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 1 / 10 | 1 / 10 |
| other Total, other adverse events | 8 / 8 | 9 / 10 | 9 / 10 |
| serious Total, serious adverse events | 2 / 8 | 6 / 10 | 6 / 10 |
Outcome results
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.
Time frame: Study Week 1 - Study Week 36
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log | 19.61 Weeks | Standard Deviation 11.75 |
| Active Arm (Cohort 1) | Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log | 10.80 Weeks | Standard Deviation 11.5 |
| Active Arm (Cohort 2) | Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log | 18.25 Weeks | Standard Deviation 16.28 |
p-value: 0.1866Log Rank
p-value: 0.2627Log Rank
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.
Time frame: Study Week 1 - Study Week 36
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ) | NA Weeks | — |
| Active Arm (Cohort 1) | Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ) | 16.79 Weeks | Standard Deviation 13.57 |
| Active Arm (Cohort 2) | Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ) | 8.18 Weeks | Standard Deviation 6.46 |
p-value: 0.0639Log Rank
p-value: 0.0508Log Rank