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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06357871
Acronym
NEPHROTOX
Enrollment
100
Registered
2024-04-10
Start date
2023-11-28
Completion date
2025-12-31
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapeutic Toxicity

Brief 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.

Interventions

OTHERNo intervention

No intervention

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPIbetween January 2020 and December 2024

Countries

France

Contacts

Primary ContactAdrien Flahault, MD, PhD
a.flahault@chru-nancy.fr+33 3 83 15 31 69

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026