New antibody treatment aims to protect transplanted kidneys from common virus
NCT ID NCT05769582
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an antibody drug called AntiBKV in 95 kidney transplant patients with BK virus infection. The virus can damage the new kidney if not controlled. Patients received four doses of the drug or a placebo over four months. The goal was to see if the drug could clear the virus from the blood and prevent kidney injury.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AntiBKV (an antibody drug given by IV infusion)
- What this could lead to
- If it works, this could offer a new treatment to control BK virus in kidney transplant patients, reducing the risk of kidney damage and graft loss.
- What could go wrong
- This is an early-to-mid stage trial with only 95 participants. The drug may not clear the virus effectively, and side effects from the infusion or immune reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
95 people
The number who actually took part.
- Started
-
Apr 2023
- Finished
-
Jul 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female aged 18 years or older 2. Kidney transplantation within 24 months prior to enrollment 3. Kidney transplant recipient with first-time BKV DNAemia (evaluated during routine clinical monitoring by the local laboratory and acknowledged by a physician within four months prior to Day 1). BKV DNAemia is either defined by BKV-DNAemia of one time \>10,000 copies/mL, or \>1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements. Note: The second, most recent laboratory value must be acknowledged by a physician within four months prior to Day 1) 4. Kidney transplant recipients with adequate and/or stable allograft function as indicated by estimated glomerular filtration rate ((e)GFR) ≥ 30 mL/min 5. Female subjects (if of childbearing potential) must agree to use adequate and reliable contraceptive measures throughout their participation in the trial. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 6. Ability to provide written informed consent Exclusion Criteria: 1. Patients with previous diagnosis of BKV DNAemia (defined as one time \> 10,000 copies/mL, or \> 1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements) since last kidney transplantation 2. Known hypersensitivity to any component of the IMP 3. Transplanted kidney disease with an estimated glomerular filtration rate ((e)GFR) \< 30 mL/minute at screening 4. Uncontrolled acute or chronic infection other than BKV infection at screening which might interfere with study participation at the discretion of the investigator 5. Recipients who are treated or planned to be treated with a mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the study period 6. Recipients who are treated or planned to be treated during study participation with leflunomide at the time of enrollment and during the study period 7. Recipients who 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) 8. Recipients with active kidney transplant rejection or FSGS 9. Recipients who have medical conditions or receive concomitant medications that prevent the recipient from undergoing allograft biopsy 10. Recipients with known DSA (de novo or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (\< 1000 mean fluorescence intensity (MFI)) can be included if no impact on the study assessments is expected by the discretion of the investigator. 11. (exclusion criterium deleted) 12. Recipients with extremely high BKV DNAemia (\> 10,000,000 copies/ml) or hemorrhagic cystitis 13. Recipients who in the opinion of the investigator are likely to develop recurrent native kidney disease (e.g. IgA nephritis, FSGS, C3 glomerulonephritis) 14. Recipients with a functionally significant ureteral stricture 15. Pregnant or nursing (lactating) women 16. Known current active or latent TB or any history, in the opinion of the investigator, that confers a risk of reactivation of latent TB and precludes the use of conventional immunosuppression 17. History of splenectomy or asplenia 18. Any condition, that in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of the participant safety data or study results 19. History of malignancy within the past five years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least two years prior to screening 20. Participation in another interventional clinical trial during trial participation or within 30 days prior to the IMP dosing or planned dosing 21. History of alcoholism or drug addiction within one year of screening. Substance use disorder will be an exclusion criterion, at investigator's discretion.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for BK viremia; BKV dnaemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
-
Cleveland Clinic
Cleveland, Ohio, 44195, United States
-
Hartford Hospital
Hartford, Connecticut, 06105, United States
-
Harvard Medical School
Boston, Massachusetts, 02215, United States
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
-
Mayo Clinic
Phoenix, Arizona, 85054, United States
-
Mayo Clinic Transplant Center
Jacksonville, Florida, 32224, United States
-
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
-
Metrolina Nephrology Associates (MNA), PA
Charlotte, North Carolina, 28207, United States
-
New York Presbyterian Hospital - Weill Cornell Medical Center
New York, New York, 10065, United States
-
Ohio State University
Columbus, Ohio, 43210, United States
-
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
-
UT Southwestern
Dallas, Texas, 75390, United States
-
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
-
University of California Davis
Sacramento, California, 95817, United States
-
University of California, Los Angeles
Los Angeles, California, 90024, United States
-
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
-
University of Maryland
Baltimore, Maryland, 21201, United States
-
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
-
University of Pennsylvania Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
-
University of Washington Medical Center
Seattle, Washington, 98195, United States
-
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
-
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.