Prediction of BKvirus Nephropathy Risk by the NEPHROVIR Method in Kidney Transplant Patients With BKvirus Viremia (BK-VIR)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    100
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 27 May 2022
kidney transplant
renal impairment
immunosuppressants
immunosuppression

Summary

BKvirus associated nephropathy (BKvAN) is a major complication in kidney transplantation. Due to BKvirus (BKv) intra-graft replication, BKvAN affects nearly 10% of patients and causes graft loss in more than 50% of cases. Without current antiviral therapy, the treatment consists of minimizing immunosuppression, secondarily exposing the patient to a graft rejection risk. Impaired BKv specific T cell response plays a crucial role in the BKvAN pathophysiology. Several teams, including ours, have demonstrated a profound impairment of BKv specific T cell response during BKvAN. Immunovirological monitoring allows an individual assessment of viral reactivation risk based on the anti-viral immune response. Our group has developed the NEPHROVIR method. This non-invasive biological method for BKvAN allows the identification of BKvAN risk level. The aim of this work is to evaluate, by the NEPHROVIR method, the risk to develop a BKvAN with renal impairment in kidney transplant recipients with sustained BKv viremia.

The investigators propose the BKVIR study. This is a prospective multicentric study involving 100 kidney transplant recipients with sustained BKv viremia. The aim of this work is to evaluate the NEPHROVIR method as an innovative immunovirological surveillance method for predicting the risk of BKvAN occurrence. The characterization of individual BKvAN risk level could help in the individualized follow-up and management of immunosuppression in patients. The long-term objective would be to diagnose very early, or even anticipate, the occurrence of BKvAN and to allow early readjustment of the immunosuppressive treatment.

Description

BKvirus associated nephropathy (BKvAN) is a major complication in kidney transplantation. Due to BKvirus (BKv) intra-graft replication, BKvAN affects nearly 10% of patients and causes graft loss in more than 50% of cases. Without current antiviral therapy, the treatment consists of minimizing immunosuppression, secondarily exposing the patient to a graft rejection risk. Impaired BKv specific T cell response plays a crucial role in the BKvAN pathophysiology. Several teams, including ours, have demonstrated a profound impairment of BKv specific T cell response during BKvAN. Immunovirological monitoring allows an individual assessment of viral reactivation risk based on the anti-viral immune response. Our group has developed the NEPHROVIR method. This non-invasive biological method for BKvAN allows the identification of BKvAN risk level. The aim of this work is to evaluate, by the NEPHROVIR method, the risk to develop a BKvAN with renal impairment in kidney transplant recipients with sustained BKv viremia.

The investigators propose the BKVIR study. This is a prospective multicentric study involving 100 kidney transplant recipients with sustained BKv viremia. Four kidney transplant centers (APHP hospitals) will participate to the study. To ensure sustained BKv viremia, only kidney transplant recipients with a confirmed plasma BKv viral load ≥ 103 copies/ml on 2 consecutive blood BKv PCR values for a duration ≥ 1 month will be eligible for the study. The investigators wish to correlate the occurrence of BKvAN with the results of the NEPHROVIR method. The primary endpoint will be the occurrence of histologically proven BKvAN associated with renal impairment within 12 months of the initial NEPHROVIR assessment. Secondary endpoints of this work are multiple, including the evaluation of the reconstitution delay of BKv specific T cell response; as well as the evaluation of the NEPHROVIR method prognosis on BKv infection and renal graft function. The expected duration of the research is 42 months. The inclusion period will be 18 months. The duration of patient follow-up will be 24 months post-inclusion. The NEPHROVIR method will be performed in the included patients at 3 distinct points: at D0 of inclusion, at 3 months and 6 months of inclusion. The NEPHROVIR method requires an additional and minimal collection of human body product (14 ml of whole blood) from a peripheral venous blood sample. Statistical analyses will be performed at the end of the follow-up period for all patients. All confidence intervals will be calculated at the 5% first-species risk and the results of the statistical tests will be given at the 5% two-sided threshold. The statistical analysis will be performed by the biostatisticien at the Clinical Research Unit Paris Saclay, using SAS® software or R software in the last version at the time of the analyses. The aim of this work is to evaluate the NEPHROVIR method as an innovative immunovirological surveillance method for predicting the risk of BKvAN occurrence. The characterization of individual BKvAN risk level could help in the individualized follow-up and management of immunosuppression in patients. The long-term objective would be to diagnose very early, or even anticipate, the occurrence of BKvAN and to allow early readjustment of the immunosuppressive treatment.

Details
Condition BK Virus Infection, Nephropathy, Kidney Transplantation
Treatment Blood sample
Clinical Study IdentifierNCT05026021
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Renal transplant patients with a plasma of BK-v ≥ 103 copies/ml confirmed on 2 consecutive blood BK-V PCR values for a period of ≥ 1 month
Men or women aged at least 18 years old - No other organ transplant except kidney transplant - Informed patient who did not object to participating in the study - Beneficiary of a social security scheme or entitled

Exclusion Criteria

Renal transplant patients with a plasma viral load of BK-v ≥ 103 copies/ml on an isolated BK-v PCR value
Progressive cancer apart from localized skin cancers - Occurence of acute rejection during the month prior to inclusion - Chronic progressive infectious disease (tuberculosis, replicating viral hepatitis Bor C, HIV infection), - Patient who has not had a biopsy to confirm or not the diagnosis of BKv nephropathy. - Patient under guardianship / curatorship - Patient under State Medical Aid
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note