RecruitingPhase 2interventionalRules rewrite

Phase 2: testing AIC263029 for BK Virus Infection

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.

Official registry: https://clinicaltrials.gov/study/NCT07503561 · AiCuris Anti-infective Cures AG · enrollment listed as 24

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are AIC263029, or Placebo. The registry lists allocation as randomized. 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).

They plan to enroll about 24 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Operationally Seamless Phase 2/3 Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of AIC263029 in the Treatment of BKV Infection in Kidney Transplant Recipients

Interventions: AIC263029, Placebo

Primary outcome (registry wording): Frequency and severity of treatment-emergent adverse events (TEAEs)

Who it is for (from inclusion criteria)

Ages 18 Years to any
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
Male participants must agree to refrain from donating sperm, and to remain abstinent (refrain from heterosexual intercourse) or use a condom with a female partner of childbearing potential until the end of the trial

Who the registry excludes

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
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 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)

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

14 listed

University of Alabama at Birmingham Hospital — Birmingham, Alabama (recruiting)
Keck Hospital of University of Southern California (USC) — Los Angeles, California (recruiting)
UCLA College of Medicine — Los Angeles, California (recruiting)
Tampa General Hospital — Tampa, Florida (recruiting)
Emory University — Atlanta, Georgia (recruiting)
University of Chicago Medical Center — Chicago, Illinois (recruiting)
University of Maryland Medical Center — Baltimore, Maryland (recruiting)
Barnes-Jewish Hospital - St. Louis (Washington University Medical Campus) — St Louis, Missouri (recruiting)
Cooperman Barnabas Medical Center — Livingston, New Jersey (recruiting)
New York-Presbyterian - Weill Cornell Medical Center — New York, New York (recruiting)
Wake Forest School of Medicine — Winston-Salem, North Carolina (recruiting)
University Hospitals Cleveland Medical Center — Cleveland, Ohio (recruiting)

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FAQ about this NCT record

Is NCT07503561 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07503561?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07503561?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary