A Phase 2 interventional study of MAU868 and Placebo in BK Virus Infection, sponsored by Vera Therapeutics, Inc.. Completed at 18 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Vera Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
Vera Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
Drug: MAU868
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
Drug: MAU868
Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
Drug: MAU868
5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
Other: Placebo
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
250 mL D5W placebo IV to be labeled to match that of MAU868
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
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
| Milestone | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) |
|---|---|---|---|
| Started | 8 | 11 | 11 |
| Completed | 8 | 9 | 9 |
| Not completed | 0 | 2 | 2 |
| Withdrew: Adverse event | 0 | 1 | 1 |
| Withdrew: Randomized but not treated | 0 | 1 | 1 |
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
| Weeks | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) |
|---|---|---|---|
| Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log | 19.61 ± 11.75 | 10.80 ± 11.50 | 18.25 ± 16.28 |
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
| Weeks | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) |
|---|---|---|---|
| Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ) | NA ± NA | 16.79 ± 13.57 | 8.18 ± 6.46 |
Collected over Study Week 1 - Study Week 36. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/8 (0%) | 2/8 (25%) | 8/8 (100%) |
| Active Arm (Cohort 1) | 1/10 (10%) | 6/10 (60%) | 9/10 (90%) |
| Active Arm (Cohort 2) | 1/10 (10%) | 6/10 (60%) | 9/10 (90%) |
| Event | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) |
|---|---|---|---|
| Diabetic ketoacidosisMetabolism and nutrition disorders | 0/8 | 2/10 | 1/10 |
| Oesophageal candidiasisInfections and infestations | 1/8 | 0/10 | 0/10 |
| Transaminases increasedInvestigations | 1/8 | 0/10 | 0/10 |
| HypercalcaemiaMetabolism and nutrition disorders | 1/8 | 0/10 | 0/10 |
| Bone marrow failureBlood and lymphatic system disorders | 0/8 | 1/10 | 0/10 |
| Acute myocardial infarctionCardiac disorders | 0/8 | 1/10 | 0/10 |
| DiarrhoeaGastrointestinal disorders | 0/8 | 1/10 | 0/10 |
| HerniaGeneral disorders | 0/8 | 0/10 | 1/10 |
| Transplant rejectionImmune system disorders | 0/8 | 0/10 | 1/10 |
| Corona virus infectionInfections and infestations | 0/8 | 1/10 | 1/10 |
| Event | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) |
|---|---|---|---|
| HypertensionVascular disorders | 3/8 | 1/10 | 1/10 |
| Blood creatinine increasedInvestigations | 1/8 | 0/10 | 3/10 |
| AnaemiaBlood and lymphatic system disorders | 2/8 | 1/10 | 0/10 |
| BK virus infectionInfections and infestations | 2/8 | 1/10 | 0/10 |
| NauseaGastrointestinal disorders | 0/8 | 2/10 | 0/10 |
| Urinary tract infectionInfections and infestations | 0/8 | 2/10 | 1/10 |
| DizzinessNervous system disorders | 1/8 | 2/10 | 0/10 |
| LeukopeniaBlood and lymphatic system disorders | 1/8 | 0/10 | 0/10 |
| Abdominal painGastrointestinal disorders | 1/8 | 0/10 | 0/10 |
| DiarrhoeaGastrointestinal disorders | 1/8 | 1/10 | 0/10 |
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. Overall Number of Baseline Participants was based on 28 randomized and treated participants.
| Age, Categorical(Participants) | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 8 | 20 |
| >=65 years | 2 | 4 | 2 | 8 |
| Age, Continuous(years) | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) | Total |
|---|---|---|---|---|
| Mean | 52.5 ± 16.85 | 60.1 ± 13.52 | 56.2 ± 8.50 | 56.5 ± 12.97 |
| Sex: Female, Male(Participants) | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) | Total |
|---|---|---|---|---|
| Female | 3 | 1 | 1 | 5 |
| Male | 5 | 9 | 9 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 2 | 5 |
| Not Hispanic or Latino | 8 | 7 | 8 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 1 | 9 |
| White | 3 | 4 | 7 | 14 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 2 | 3 |
| Region of Enrollment(Participants) | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) | Total |
|---|---|---|---|---|
| Canada | 0 | 1 | 2 | 3 |
| United States | 8 | 9 | 8 | 25 |
| eGFR (CK-EPI)(mL/min/ 1.73m^2)(mL/min/ 1.73m^2) | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) | Total |
|---|---|---|---|---|
| Mean | 59.5 ± 21.23 | 54.1 ± 22.93 | 51.1 ± 11.53 | 54.6 ± 18.66 |
| Time from Kidney Transplant (days)(Days) | Placebo | Active Arm (Cohort 1) | Active Arm (Cohort 2) | Total |
|---|---|---|---|---|
| Mean | 174.6 ± 82.57 | 175.6 ± 93.53 | 143.5 ± 89.72 | 163.9 ± 87.21 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2020 to primary completion in Feb 2022, 18 months.
Results were first posted in May 2023, 1 year 3 months after primary completion.
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Vera Therapeutics, Inc.