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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06650111
Acronym
NETI-MULTI
Enrollment
224
Registered
2024-10-21
Start date
2025-03-17
Completion date
2025-12-15
Last updated
2026-04-03

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

Conditions

Nephritis, Interstitial

Keywords

Tubulointerstitial nephritis (TIN)

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.

Interventions

OTHERRereading 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.

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).

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of glomerular filtration rate and renal survivalTime 0Evolution of glomerular filtration rate and renal survival (defined as the persistence of sufficient renal function not requiring the use of a replacement technique) over time and according to etiology.

Secondary

MeasureTime frameDescription
Significant association between renal prognosis with specific predictive factorsTime 0Significant association between renal prognosis, defined by glomerular filtration rate and/or end-stage renal dysfunction with specific predictive factors. Description of Clinical (age, sex, etiology, high blood pressure, diabetes, early extra-renal purification, AKI stage), biological (peak creatinine, hemoglobin, calcemia, proteinuria, hematuria) and histological factors (interstitial infiltrate, tubulitis, presence of granulomas, fibrosis).
Response to corticosteroid therapyTime 0Evolution of glomerular filtration rate and renal survival over time as a function of corticosteroid treatment.
Association between response to corticosteroid therapy and some histological criteriaTime 0Association between response to corticosteroid therapy and some histological criteria. Description of histological criteria : interstitial infiltrate, tubulitis, presence of granulomas, fibrosis.
Evaluate the contribution of histological analysis in etiological diagnosisTime 0Performance of pathologist review in establishing blind histological diagnosis.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMarion Rabant, M.D., PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

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