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

Not yet recruiting

• Conditions: Nephritis, Interstitial

• Registration Number: NCT06650111
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-17
• Study First Submitted QC: 2024-10-17
• Last Update Submitted: 2024-10-17
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21
• Study Start: 2024-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of glomerular filtration rate and renal survival	Time 0	Evolution 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 Outcome Measures

Name	Time	Method
Significant association between renal prognosis with specific predictive factors	Time 0	Significant 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 therapy	Time 0	Evolution of glomerular filtration rate and renal survival over time as a function of corticosteroid treatment.
Association between response to corticosteroid therapy and some histological criteria	Time 0	Association 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 diagnosis	Time 0	Performance of pathologist review in establishing blind histological diagnosis.

Trial Locations

Locations (3)

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France

Hôpital Tenon; 🇫🇷 Paris, France