A Study to Understand How a New, Unlicensed Drug (AIC468) Works, Compared With a Placebo, Against… (NCT07503561) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Understand How a New, Unlicensed Drug (AIC468) Works, Compared With a Placebo, Against BK Virus in Patients Who Have Had a Kidney Transplant.
24 participantsStarted 2026-06-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female aged 18 years or older
. Kidney transplantation within 12 months prior to randomization
. First episode of detectable BKV DNA in plasma since last kidney transplantation. As defined by either:
. 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.
. Female participants (if of childbearing potential) must agree to remain abstinent (refrain from heterosexual intercourse) or use at least one highly effective contraceptive method that result in a failure rate of \<1% per year until the end of the trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and severity of treatment-emergent adverse events (TEAEs)
. Negative serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test prior to randomization on Day 1.
. Able and willing to provide written informed consent and comply with trial protocol.
Exclusion criteria
. Known hypersensitivity to any component of the IMP
. 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
. Participants who have received a multi-organ transplant involving a kidney (e.g. kidney-pancreas, kidney-liver, kidney-heart)
. Participants who are treated or planned to be treated during trial participation with leflunomide, cidofovir, or medicinal products potentially active against BKV at the time of randomization and during the trial period until end of treatment.
. Participants who received antibody-depletion therapy within 3 months prior to randomization, or in the opinion of the Investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depletion therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)
. Participants with active kidney transplant rejection or those considered at high-risk of recurrence of native kidney disease (e.g. primary focal segmental glomerulosclerosis \[FSGS\], C3 glomerulopathy)