Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer (NEPHROTOX)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Chemotherapeutic Toxicity

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06357871

2023PI178

Details and patient eligibility

About

Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.

Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.

We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient over 18 years old Diagnosis of solid cancer treated by immunotherapy such as checkpoint inhibitor, associated or not with chemotherapy Renal failure having benefited from a renal biopsy

Exclusion criteria

• None

Trial design

100 participants in 2 patient groups

Test cohort

Description:

To establish the score

Treatment:

Other: No intervention

Validation cohort

Description:

To validate the score

Treatment:

Other: No intervention