CMVIG for Kidney Complications
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how Cytogam, an immunoglobulin therapy, might help kidney transplant patients avoid infection with cytomegalovirus (CMV), a common virus that can cause complications after a transplant. Researchers will test different dosing schedules to observe the body's reactions and assess the prevention of these infections. The trial seeks kidney transplant patients who have received an organ from a CMV-positive donor but are CMV-negative themselves. Participants should already be receiving belatacept, a specific type of medication. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking advancements in transplant care.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot participate if you are receiving IgG therapy or have received it within two months before joining the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the FDA has approved Cytogam to help prevent CMV (cytomegalovirus) in kidney transplant recipients. This approval indicates its safety for use in medical settings. However, some safety concerns exist. Like similar products, Cytogam has been linked to kidney problems, including kidney dysfunction and, in severe cases, kidney failure. In rare situations, these issues have resulted in death. While Cytogam appears promising in protecting transplant patients from CMV, understanding these potential risks is important. Prospective participants should discuss these factors with their healthcare provider.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments being tested for kidney complications because they use Cytogam, a form of CMVIG, in combination with Belatacept to potentially reduce complications after kidney transplants. Unlike the standard antiviral medications typically used, these treatments focus on enhancing the immune response with intravenous immunoglobulin specifically designed to target cytomegalovirus (CMV). The trial explores different dosing schedules, including a single dose and two doses administered at varying intervals, to determine the most effective regimen. This innovative approach could lead to more targeted and efficient ways to protect kidney transplant patients from CMV-related issues, offering hope for better post-transplant outcomes.
What evidence suggests that this trial's treatments could be effective for preventing CMV in kidney transplant patients?
Research has shown that Cytogam, a product used to prevent CMV infections, may benefit organ transplant patients. It is considered for those receiving kidney, lung, heart, or liver transplants. Cytogam aids the immune system in fighting CMV, a virus that can cause serious problems for transplant patients. Some studies indicate that while it may lower the risk of CMV infections, it doesn't always prevent issues like organ rejection. Cytogam uses antibodies to directly target the virus. In this trial, participants will receive different dosing regimens of Cytogam to evaluate its effectiveness in preventing kidney complications. Although the results are promising, more research is needed to confirm its efficacy in preventing kidney problems.24678
Who Is on the Research Team?
Vanessa Humphreville, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
Adult kidney transplant recipients aged 18-70, who are either switching to or stable on belatacept immunosuppression. They must be EBV IgG Positive and CMV Ig Seronegative with a seropositive donor. Excluded are pregnant individuals, non-English speakers needing translation for consent, those unwilling to sign consent or complete follow-ups, and subjects with IgA deficiency or recent IgG therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CMVIG and Belatacept infusions according to assigned dosing regimens
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cytogam
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor