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

NCT ID: NCT06650111

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients

Patients whose biopsy of the care revealed tubulointerstitial nephritis in the foreground and retained as the main cause of renal dysfunction after etiological investigation.

The biopsies concerned were carried out between 01/01/2010 and 31/12/2019. The clinical follow-up data of the patients from whom the biopsies were taken will be collected until the date of the last follow-up (before 31/12/2021).

Rereading of biopsies

Intervention Type: OTHER

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.

Collection of data from the patient's medical file

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients who do not object to the use of their medical data and samples for this research
• With a biopsy of the care on native kidney and subject to a biological collection, finding tubulointerstitial nephritis in the foreground and retained as the main cause of renal dysfunction after etiological investigation.
• Signs of histological activity of the NTI objectified during the centralized rereading and defined by:

• An inflammation of more than 10% of the surface of the entire cortical parenchyma (fibrous and non-fibrous) or a ti score > or = 1 according to the Banff classification
• AND/OR the presence of at least one granuloma on the biopsy

Exclusion Criteria

• No access to medical records for data collection, or insufficient clinical data
• Follow-up less than 3 months
• Histological lesions of the tubulointerstitial sector but related to a hematological, urological, genetic etiology or the direct tubular toxicity of a drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marion Rabant, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Européen Georges Pompidou

Paris, , France

Site Status: RECRUITING

Hôpital Necker-Enfants Malades

Paris, , France

Site Status: RECRUITING

Hôpital Tenon

Paris, , France

Site Status: ACTIVE_NOT_RECRUITING

Countries

France

Central Contacts

Marion Rabant, M.D., PhD

Role: CONTACT

marion.rabant@aphp.fr

0033144495716

Hélène Morel

Role: CONTACT

0033171196346

Facility Contacts

Alexandre Karras, M.D., PhD

Role: primary

alexandre.karras@aphp.fr

Marion Rabant, M.D., PhD

Role: primary

marion.rabant@aphp.fr

0033144495716

Other Identifiers

APHP240673

Identifier Type: -

Identifier Source: org_study_id