BK Virus InfectionPhase 2NCT07503561
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
A Phase 2 study testing AIC263029 in people with BK Virus Infection and BKV Infection, run by AiCuris Anti-infective Cures AG at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Virus Infection, BKV Infection, Kidney Transplant
- What is being tested?
- AIC263029
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Oct 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
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- 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)
- Participants with known donor-specific antibodies ([DSA], de novo, or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (<1,000 mean fluorescence intensity [MFI]) can be included if no impact on the trial assessments is expected by the discretion of the Investigator.
- Pregnant or nursing (lactating) women
- Uncontrolled acute or chronic infections such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV), cytomegalovirus (CMV), or Epstein-Barr virus (EBV)
- History of malignancy within the past 5 years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least 2 years prior to screening
- Documented evidence of the use of another Investigational Medicinal Product (IMP) within 30 days or 5 half-lives of randomization, or until the expected PD effect has returned to baseline (whichever is longer)
- Known current alcoholism or drug addiction
- Any other condition or laboratory abnormality, that in the opinion of the Investigator, would interfere with the evaluation of the IMP or interpretation of the participant safety data or trial results.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
George Marshall Lyon, MD, 404-712-2051, gmlyon@emory.edu
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Abdolreza Haririan, 4103287648, ahariria@som.umaryland.edu
- Recruiting
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249
Clifton Marshall Kew, MD, 205-934-4011, ckew@uab.edu
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
David Axelrod, 3193561334, David.Axelrod@UHhospitals.org
- Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Anup Patel, 9733222146, anup.patel@rwjbh.org
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Amber Anwar, MD, 813-347-2878, aanwar@flkidney.com
- Recruiting
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27101
Ryan Maves, 3367162700, ryan.maves@wfusm.edu
About this study
Official title: 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
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.
Read the detailed description
This study is Part A (Phase 2a) of a randomized, double-blind, placebo-controlled clinical trial evaluating AIC263029 in adult kidney transplant recipients with BK virus (BKV) viremia. Part A is designed to assess safety and tolerability of multiple dose levels, characterize pharmacokinetics (PK), and explore antiviral activity based on changes in plasma BKV DNA.
In Part A, participants are enrolled into sequential dose cohorts. Within each cohort, participants are randomized in a 3:1 ratio to receive AIC263029 or matching placebo. Three dose levels are planned (100 mg, 200 mg, and 330 mg). Study drug is administered as subcutaneous injections once weekly, for a total of five injections over a 4-week treatment period. Up to three additional optional cohorts may be added based on emerging safety, PK, and antiviral activity data.
Participants undergo screening (up to approximately 30 days), followed by the 4-week treatment period and a follow-up period of up to approximately 24 weeks after the end of treatment. Safety evaluations include monitoring of treatment-emergent adverse events, adverse events of special interest (including injection site reactions and kidney transplant outcomes such as graft loss and acute/chronic rejection), and clinically significant changes in laboratory parameters, vital signs, and electrocardiograms. PK sampling is performed to estimate standard PK parameters. Antiviral activity is assessed by quantitative plasma BKV DNA measurements over time, including assessment of change from baseline and time to clinically meaningful reductions. Viral genotyping/resistance monitoring may be performed to assess baseline polymorphisms and potential treatment-emergent resistance.
- Conditions
- BK Virus Infection, BKV Infection, Kidney Transplant
- Being tested
- AIC263029, Placebo
- Keywords
- BK Virus, BK Viremia in kidney transplant, antisense oligonucleotide, AIC263029, AIC468
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIC263029Drug
AIC263029 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).
PlaceboDrug
Matching placebo administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| AIC263029 | Experimental | 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. Receives: Drug: AIC263029 |
| Placebo | Placebo comparator | Matching placebo administered by subcutaneous injection on the same schedule as active treatment within each cohort Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of treatment-emergent adverse events (TEAEs)
Frequency and severity of treatment emergent adverse events
Measured: Day 1 to Day 30 of the dosing period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start5 Oct 2026
- Primary completion17 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BK Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Group-sequential multiple-dose cohorts with within-cohort 3:1 randomization to AIC263029 vs placebo; weekly dosing over 4 weeks; optional additional cohorts may be added.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AiCuris Anti-infective Cures AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503561
- Sponsor's protocol ID
- AIC468-01-II/III-01
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07503561
- Acronym / sponsor ID
- AIC468-01-II/III-01
- Conditions
- BK Virus Infection, BKV Infection, Kidney Transplant
- Keywords
- BK Virus, BK Viremia in kidney transplant, antisense oligonucleotide, AIC263029, AIC468
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AiCuris Anti-infective Cures AGIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 17 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is Part A (Phase 2a) of a randomized, double-blind, placebo-controlled clinical trial evaluating AIC263029 in adult kidney transplant recipients with BK virus (BKV) viremia. Part A is designed to assess safety and tolerability of multiple dose levels, characterize pharmacokinetics (PK), and explore antiviral activity based on changes in plasma BKV DNA.
In Part A, participants are enrolled into sequential dose cohorts. Within each cohort, participants are randomized in a 3:1 ratio to receive AIC263029 or matching placebo. Three dose levels are planned (100 mg, 200 mg, and 330 mg). Study drug is administered as subcutaneous injections once weekly, for a total of five injections over a 4-week treatment period. Up to three additional optional cohorts may be added based on emerging safety, PK, and antiviral activity data.
Participants undergo screening (up to approximately 30 days), followed by the 4-week treatment period and a follow-up period of up to approximately 24 weeks after the end of treatment. Safety evaluations include monitoring of treatment-emergent adverse events, adverse events of special interest (including injection site reactions and kidney transplant outcomes such as graft loss and acute/chronic rejection), and clinically significant changes in laboratory parameters, vital signs, and electrocardiograms. PK sampling is performed to estimate standard PK parameters. Antiviral activity is assessed by quantitative plasma BKV DNA measurements over time, including assessment of change from baseline and time to clinically meaningful reductions. Viral genotyping/resistance monitoring may be performed to assess baseline polymorphisms and potential treatment-emergent resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group-sequential multiple-dose cohorts with within-cohort 3:1 randomization to AIC263029 vs placebo; weekly dosing over 4 weeks; optional additional cohorts may be added.
| Arm | Type | Receives |
|---|---|---|
| AIC263029 | Experimental | Drug: AIC263029Weekly 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. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo administered by subcutaneous injection on the same schedule as active treatment within each cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIC263029AIC263029 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). | Drug | AIC263029 |
| PlaceboMatching placebo administered by subcutaneous injection | Drug | Placebo |
Primary outcome
Frequency and severity of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 to Day 30 of the dosing period.
Frequency and severity of treatment emergent adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
Related trials for BK Virus Infection
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Viral Infection
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25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
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Enrolling by invitationObservational study
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
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Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AIC263029 in people with BK Virus Infection and BKV Infection, run by AiCuris Anti-infective Cures AG at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of treatment-emergent adverse events (TEAEs) (time frame: Day 1 to Day 30 of the dosing period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.