View clinical trials related to BK Virus Nephropathy.
Filter by:There has been no effective predicting tool to accurately predict BKV reactivation after kidney transplantation. The aim is to elucidate the use of flow cytometric analysis for both intracellular cytokines and surface activation markers for BKV-specific T cell response in kidney transplant recipients.
BK virus (BKV) is a member of the polyomavirus family with a prevalence of up to 90% in the general population. In immunocompromized individuals, such as kidney transplant recipients (KTRs) who receive immunosuppressant therapy to prevent graft rejection, BKV turns into an opportunistic pathogen. BK viremia has been reported to occur in 10-30% of KTRs. BKV is recognized as a leading cause of impaired graft function and premature transplant loss, and is therefore a serious condition in kidney transplant patients. At present, there are no effective agents specifically against BKV available and thus no standard treatment that can effectively reduce or prevent BKV infection/reactivation after renal transplantation. Therefore, the proposed indication for the AntiBKV neutralizing antibody is the treatment of BK virus infections and prevention of BK virus associated complications in KTRs. This study has been designed to evaluate the safety, tolerability, and pharmacokinetic of ascending doses of AntiBKV, a fully human highly neutralising antibody against BKV, administered as a single or multiple intravenous infusions to healthy adult participants. The data obtained in this study will provide the basis for further clinical development of AntiBKV.
The purpose of this study is to compare Posoleucel (formerly known as ALVR105; Viralym-M) to placebo in kidney transplant recipients who have high or low levels of BK virus in their blood.
Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing "Virus-like particles" (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.
The objective of the VIRTUUS Children's Study is to adapt identified and validated adult noninvasive diagnostic and prognostic biomarkers for the characterization of allograft status in pediatric recipients of kidney allografts.
This study is being conducted to determine whether MAU868 warrants further clinical development for the prevention of BKV infection in kidney transplant recipients.
The investigator's aim in this study is to evaluate the impact of a new standard of care protocol for the treatment of BK viremia and nephropathy (BKVAN), which includes switching from Tacrolimus to equivalent dose of Cyclosporine in patients who have been diagnosed with BK viremia or BKVAN based on their viral load, overall graft function (estimated glomerular filtration rate), acute rejection, and rate of graft loss due to rejection or BKVAN.
This study will look at the safety, tolerability and effectiveness of cidofovir in kidney transplant patients who have been diagnosed with BK virus nephropathy (BKVN), a viral condition that can cause patients to reject transplanted kidneys. Up to 48 adult (age 18 years and older) kidney or pancreas transplant recipients with newly diagnosed BKVN will receive 1 of 3 cidofovir dose levels or placebo (non medicated substance) to identify the maximum tolerated dose. Dosing will be administered intravenously (by a tube running into a blood vessel). In addition to the screening visit, volunteers will actively participate for approximately 8-10 weeks with a single follow up phone call at 4 months. Blood samples, urine samples, eye exams and physical exams are included in study procedures.