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

Chemotherapeutic Toxicity Clinical Trial

— NEPHROTOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06357871
• Other study ID #: 2023PI178
• Status: Recruiting
• Start date: November 28, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Central Hospital, Nancy, France
• Contact: Adrien Flahault, MD, PhD
• Phone: +33 3 83 15 31 69
• Email: a.flahault[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre les nancy

Sponsors (5)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Centre Hospitalier Régional Metz-Thionville, CHU de Reims, European Georges Pompidou Hospital, University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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