NCT06650111

Epidemiology, Diagnosis, Medical Care and Prognosis of Tubulointerstitial Nephritis: Results of a Multicenter Retrospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 224 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tubulointerstitial nephritis (TIN), diagnosed on kidney biopsy, represents a common cause of kidney failure. The etiologies are multiple but the diagnosis of the causative disease is sometimes difficult and the treatment is not completely codified. The research focuses on the characterization of TIN on the etiological, clinical, biological, therapeutic and prognostic levels in order to improve patient care. For this purpose, kidney biopsies performed for the diagnosis, kept in a biological collection within the biological resource platforms of the Necker-Enfants Malades hospital and the Georges Pompidou hospital will be centrally reviewed, blinded to the final diagnosis.

Detailed description

Tubulointerstitial nephritis (TIN) is defined as a diverse set of renal pathologies caused by a primary lesion of the interstitial compartment, which most often extends to the associated tubular structures. Renal histology establishes the diagnosis by objectifying different types of lesions associated to varying degrees depending on the etiology and clinical course. These lesions are: an interstitial inflammatory infiltrate whose nature is largely dependent on the etiopathogenic mechanisms of the lesion, diffuse or multifocal interstitial fibrosis, tubular epithelial lesions in the form of tubulitis and/or tubular atrophy. Research focuses on the characterization of TIN on the etiological, clinical, biological, therapeutic and prognostic levels in order to try to improve patient care. For this: * 1st step: native kidney biopsies performed to establish the diagnosis and kept in a biological collection within the biological resource platforms of the Necker-Enfants Malades hospital and the Georges Pompidou hospital will be centrally reviewed The review will be performed at the Pathology department of Necker hospital, blinded to the final diagnosis for selection of the biopsies that will be included in the study. Included biopsies will be those with tubulointerstitial nephritis retained as the main cause of renal dysfunction after etiological investigation * 2nd step: collection of clinical and biological data regarding the diagnosis, management and prognosis * 3rd step: statistical analysis of the data and consolidation of the results.

Conditions

• Nephritis, Interstitial

Interventions

Type	Name	Description
OTHER	Rereading of biopsies	Rereading of biopsies, blinded to the final diagnosis, by a pathologist specializing in nephropathology. This review includes: an optical microscopy study on a fragment fixed with routine staining, an optical microscopy study on a frozen fragment, an immunohistochemical study on a frozen fragment if available.
OTHER	Collection of data from the patient's medical file	Collection of data from the patient's medical file. The clinical data of the care of patients at whom the biopsies belong will be analyzed until the date of the patient's last follow-up (before 12/31/2021).

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2024-10-21
• Last updated: 2026-04-03

Locations

3 sites across 1 country: France