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

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapeutic Toxicity
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Adrien Flahault, MD, PhD; Phone Number: +33 3 83 15 31 69; Email: a.flahault@chru-nancy.fr

Study Locations

• France
  • Vandoeuvre les nancy, France, 54500
    • Recruiting
    • CHRU de Nancy
    • Contact: Adrien Flahault, MD PhD; Phone Number: 0383858585; Email: a.flahault@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include all patients hospitalized for kidney biopsy in the context of acute renal failure with CPI treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test cohort; To establish the score	Other: No intervention; No intervention
Validation cohort; To validate the score	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI	between January 2020 and December 2024

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: University Hospital, Strasbourg, France; CHU de Reims; European Georges Pompidou Hospital; Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Adrien Flahault, MD, PhD, CHRU de Nancy

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023PI178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No