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

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)

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.

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.