The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia). The study will also examine how the body processes AIC263029 and whether it lowers BKV levels in the blood.
Researchers will compare AIC263029 to a placebo (a look-alike injection with no active drug). Participants will be assigned by chance to receive AIC263029 or placebo and will receive weekly injections under the skin for 4 weeks. Participants will have clinic visits and blood tests during treatment and follow-up to monitor safety and measure BKV levels, and will be followed for up to about 24 weeks after treatment.
Male or female aged 18 years or older
Kidney transplantation within 12 months prior to randomization
positive BKV DNA test of one time >104 IU/mL and <106 IU/mL, within 30 days prior to randomization, or
>103 IU/mL and ≤104 IU/mL sustained for at least 2 weeks (confirmed by at least 2 consecutive measurements), with the most recent measurement within 14 days prior to randomization.
Known hypersensitivity to any component of the IMP
Estimated glomerular filtration rate ([e]GFR) <30 mL/minute/1.73 m2 at screening
Alanine transaminase (ALT) >2×upper limit of normal (ULN) or direct bilirubin >1.1×ULN (except Gilbert's Disease) at screening
Uncontrolled participants who are treated or planned to be treated with an mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the trial period
Sequential
AIC263029
DrugAIC263029 supplied in vials for injection (110 mg/mL) and administered by subcutaneous injection; Part A uses weekly dosing over 4 weeks in planned dose cohorts (100 mg, 200 mg, 330 mg).
Placebo
DrugMatching placebo administered by subcutaneous injection
Frequency and severity of treatment-emergent adverse events (TEAEs)
Frequency and severity of treatment emergent adverse events
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This trial is not recruiting at the moment. You can still explore other options:
