This study is being conducted to determine whether MAU868 warrants further clinical development for the prevention of BKV infection in kidney transplant recipients.
This is a non-confirmatory, randomized, placebo-controlled, blinded, proof-of-concept study in kidney transplant recipients. Approximately 96 eligible subjects are planned to be randomized 2:1 to receive MAU868 or placebo. At least 78 subjects are expected to complete the study. The study will consist of a pre-treatment (screening) consenting period, a 24 week treatment period (consisting of 6 monthly i.v. doses of MAU868 or placebo) and a 24 week follow-up period. Subjects who complete the study per protocol will attend a total of 16 visits over a period of 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Incidence of BK viremia
\>1000 copies/mL through 24 weeks
Time frame: 24 weeks
Pharmacokinetics of MAU868
Cmin
Time frame: 48 weeks
Immunogenicity of MAU868
Investigate the potential development of anti-drug antibodies
Time frame: 48 weeks
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