AIC263029 for BK Virus Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have had a kidney transplant within the past year and currently have BK virus in their blood at certain levels. Participants must agree to use effective birth control, not donate sperm, test negative for pregnancy if female, and be able to give informed consent.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- AIC263029
Trial Overview
The study tests AIC263029 versus placebo in people with BK virus after kidney transplant. Participants are randomly assigned to get weekly under-the-skin injections of either AIC263029 or placebo for 4 weeks, with follow-up visits and blood tests over about 24 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Weekly subcutaneous AIC263029 administered over 4 weeks. Three initial dose cohorts are planned (100 mg, 200 mg, 330 mg), with 5 weekly injections over 4 weeks; within each cohort, participants are randomized 3:1 to AIC263029 vs placebo. Up to 3 additional optional cohorts may be enrolled.
Matching placebo administered by subcutaneous injection on the same schedule as active treatment within each cohort
Find a Clinic Near You
Who Is Running the Clinical Trial?
AiCuris Anti-infective Cures AG
Lead Sponsor
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