Ongoing Clinical Trials for BK Virus Infection
Currently, there is 1 ongoing clinical trial investigating the prevention of BK virus infection in kidney transplant patients. This trial is being conducted in France and focuses on using human normal immunoglobulin treatment to reduce the risk of infection in patients with low levels of protective antibodies.
Clinical trial locations
Study on Human Normal Immunoglobulin to Prevent BKV Infection in Kidney Transplant Patients with Low Antibody Levels
This clinical trial is investigating whether a treatment called Privigen can help prevent BK virus infection in people who have recently received a kidney transplant. The BK virus is a common virus that can remain inactive in the body for years but may become active again when the immune system is weakened, such as after a transplant when patients take medications to prevent organ rejection.
Main focus: The study aims to determine if giving human normal immunoglobulin can reduce the occurrence of the virus appearing in the blood of transplant patients who have low levels of natural antibodies against the virus at the time of their transplant. Researchers will monitor patients for one year after transplantation, checking for the presence of the virus in both blood and urine, as well as monitoring the overall health of the transplanted kidney.
Investigational treatment: The medication being tested is Privigen, an intravenous immunoglobulin solution containing proteins derived from human blood that help the body fight infections. This treatment is given directly into a vein and works by boosting the immune system with antibodies that can help neutralize the virus.
Who can participate: The trial is open to adults aged 18 years or older who have received a kidney transplant. Participants must be able to understand the study’s purpose and risks, provide written consent, and be covered by medical insurance. The study includes patients who may have received more than one organ transplant.
Who cannot participate: Patients who already have an active BK virus infection at the time of transplantation are not eligible. Those with very high levels of the virus in their blood or who have low levels of protective antibodies against the specific virus strain from their donor kidney cannot join the study. The trial also excludes vulnerable populations who may need special protection.
Throughout the study, participants will undergo regular assessments at specific time points: day 10, day 31, day 52, and at 3, 6, and 12 months after transplantation. The primary measure of success will be whether patients develop the virus in their blood six months after their transplant. Additional measures include monitoring antibody levels, kidney function, and overall patient health throughout the year-long study period.
Summary
Currently, only one clinical trial is actively investigating BK virus infection prevention, highlighting the specific focus on a vulnerable patient population: kidney transplant recipients with low antibody levels. This trial, conducted in France, concentrates on using intravenous immunoglobulin therapy as a preventive approach rather than treating active infection. The focus on prevention is particularly important given that BK virus reactivation can lead to serious complications in transplant patients, including potential damage to the newly transplanted kidney. The trial is expected to conclude in August 2026 and may provide valuable insights into improving outcomes for kidney transplant patients at risk of this viral complication.