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

NCT06650111 | Recruiting

• 1 other identifier: APHP240673
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Nephritis, Interstitial

Keywords

Tubulointerstitial nephritis (TIN)

Outcome Measures

Primary Outcomes (1)

• Evolution of glomerular filtration rate and renal survival

  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.

  Time 0

Secondary Outcomes (4)

• Significant association between renal prognosis with specific predictive factors

  Time 0

• Response to corticosteroid therapy

  Time 0

• Association between response to corticosteroid therapy and some histological criteria

  Time 0

• Evaluate the contribution of histological analysis in etiological diagnosis

  Time 0

Study Arms (1)

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).

Other: Rereading of biopsies; Other: Collection of data from the patient's medical file

Interventions

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.

Patients

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).

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with renal dysfunction whose main cause retained after etiological investigation is tubulointerstitial nephritis and treated at the Necker-Enfants Malades hospital or at the Georges Pompidou European hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (3)

Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

Hôpital Tenon

Paris, 75020, France

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Human native kidney biopsy from a biological collection for patient care, with fixed fragment stored at room temperature and frozen fragment stored at -80°C.

MeSH Terms

Conditions

Nephritis, Interstitial

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marion Rabant, M.D., PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Rabant, M.D., PhD

CONTACT

0033144495716; marion.rabant@aphp.fr

Hélène Morel

CONTACT

0033171196346

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: March 17, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)