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NCT Number: NCT06650111

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Européen Georges Pompidou, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rereading of biopsies

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

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).

Primary outcomes

  1. Evolution of glomerular filtration rate and renal survival

    Time frame: 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 outcomes

  1. Significant association between renal prognosis with specific predictive factors

    Time frame: 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).

  2. Response to corticosteroid therapy

    Time frame: Time 0

    Evolution of glomerular filtration rate and renal survival over time as a function of corticosteroid treatment.

  3. Association between response to corticosteroid therapy and some histological criteria

    Time frame: Time 0

    Association between response to corticosteroid therapy and some histological criteria. Description of histological criteria : interstitial infiltrate, tubulitis, presence of granulomas, fibrosis.

  4. Evaluate the contribution of histological analysis in etiological diagnosis

    Time frame: Time 0

    Performance of pathologist review in establishing blind histological diagnosis.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: NETI-MULTI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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