A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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BK Virus Infection

Intervention / Treatment
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* Drug: MAU868
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses | Drug: MAU868<br>* 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<br>|
| Experimental: Cohort 2<br>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<br>* 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<br>|
| Experimental: Cohort 3<br>Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses | Drug: MAU868<br>* 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<br>|
| Placebo Comparator: Placebo Cohort 1, 2, 3<br>5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses | Other: Placebo<br>* 250 mL D5W placebo IV to be labeled to match that of MAU868<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |