Prediction of BKvirus Nephropathy Risk by the NEPHROVIR Method in Kidney Transplant Patients With BKvirus Viremia

NCT05026021 | Active Not Recruiting

• 1 other identifier: 2020-A01443-36
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 5

Brief 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 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 BK-VIR 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.

Conditions

BK Virus Infection; Nephropathy; Kidney Transplantation

Keywords

kidney transplantation; Prediction of BK virus; Immunovirological monitoring; Associated nephropathy risk

Outcome Measures

Primary Outcomes (1)

• Evaluate by the NEPHROVIR method the risk of developing histologically proven BKvAN with renal impairment in kidney transplant recipients

  The primary endpoint is the occurrence of histologically proven BKvAN with renal impairment within a maximum of 12 months after the first NEPHROVIR assessment (at inclusion: D0). Histologically proven BKvAN with renal impairment is defined as the occurrence of renal histological lesions (nuclear inclusions in tubular epithelial cells) associated with impaired renal graft function, defined as an increase in serum creatinine of more than 25% over its basal value.

  12 months

Secondary Outcomes (4)

• Assessment of the time to reconstitution of an effective anti-BK-v immune response from baseline (inclusion) at 12 months

  Day 0 of inclusion, Month 3, Month 6 and Month 12 post-inclusion

• Assessment of the prognostic character of NEPHROVIR on BKv infection from baseline (inclusion) at 12 months

  Day 0 of inclusion, Month 3, Month 6 and Month 12 post-inclusion

• Assessment of the prognostic character of NEPHROVIR on kidney graft function from baseline (inclusion) at 24 months

  Day 0 of inclusion, Month 3, Month 6, Month 12 and Month 24 post-inclusion

• Assessment of the prognostic character of NEPHROVIR on kidney graft allorejection risk from baseline (inclusion) at 12 months

  Day 0 of inclusion, Month 3, Month 6 and Month 12 post-inclusion

Interventions

Blood sample BIOLOGICAL

For each patient blood (17 ml of whole blood) will be collected during a peripheral venous blood sample carried out in the the standard care at inclusion visit, M3 visit (3 months after inclusion), M6 visit (6 months after inclusion) and M12 visit (12 months after inclusion).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 aged at least 18 years old

You may qualify if:

• 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

You may not qualify if:

• Renal transplant patients with a plasma viral load of BK-v \<103 copies/ml or ≥ 103 copies/ml on an isolated BK-v PCR value

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• SATT Paris Saclay: collaborator

Study Sites (5)

Henri Mondor Hospital (001)

Créteil, 94000, France

Location

Saint Louis Hospital (003)

Paris, 75010, France

Location

La Pitié Salpêtrière Hospital (004)

Paris, 75013, France

Location

Necker Hospital (005)

Paris, 75015, France

Location

Foch Hospital (002)

Suresnes, 92150, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

BKvirus-specific T cells

MeSH Terms

Conditions

Kidney Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Antoine DURRBACH, profesor

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: August 30, 2021
• Study Start: September 2, 2021
• Primary Completion: September 2, 2023
• Study Completion: September 2, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)