Nephritis, InterstitialNETI-MULTINCT06650111
Epidemiology, Diagnosis, Medical Care and Prognosis of Tubulointerstitial Nephritis: Results of a Multicenter Retrospective Cohort Study
An observational study of Nephritis, Interstitial, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephritis, Interstitial
- What is being tested?
- Rereading of biopsies and Collection of data from the patient's medical file
- How many people
- 224 participants
- Where
- 3 sitesFrance
- Study dates
- 17 Mar 2025to 15 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Necker-Enfants Malades
Paris, 75015
Hôpital Tenon
Paris, 75020
About this 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.
Read the 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
- Being tested
- Rereading of biopsies, Collection of data from the patient's medical file
- Keywords
- Tubulointerstitial nephritis (TIN)
- Medical subject headings
- Nephritis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rereading of biopsiesOther
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 fileOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Rereading of biopsies; Other: Collection of data from the patient's medical file |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time 0
Secondary outcomes (4)
Significant association between renal prognosis with specific predictive factors
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).
Measured: Time 0
Response to corticosteroid therapy
Evolution of glomerular filtration rate and renal survival over time as a function of corticosteroid treatment.
Measured: Time 0
Association between response to corticosteroid therapy and some histological criteria
Association between response to corticosteroid therapy and some histological criteria. Description of histological criteria : interstitial infiltrate, tubulitis, presence of granulomas, fibrosis.
Measured: Time 0
Evaluate the contribution of histological analysis in etiological diagnosis
Performance of pathologist review in establishing blind histological diagnosis.
Measured: Time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start17 Mar 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephritis, InterstitialStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marion Rabant, M.D., PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650111
- Sponsor's protocol ID
- APHP240673
- Acronym
- NETI-MULTI
- Status last verified
- Sep 2025
- First submitted
- 17 Oct 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology, Diagnosis, Medical Care and Prognosis of Tubulointerstitial Nephritis: Results of a Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06650111
- Acronym / sponsor ID
- NETI-MULTI / APHP240673
- Conditions
- Nephritis, Interstitial
- Keywords
- Tubulointerstitial nephritis (TIN)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Rereading of biopsies, Other: Collection of data from the patient's medical filePatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rereading of biopsiesRereading 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. | Other | Patients |
| Collection of data from the patient's medical fileCollection 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). | Other | Patients |
Primary outcome
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.
4 secondary outcomes
Significant association between renal prognosis with specific predictive factors
Time frame: Time 0
Response to corticosteroid therapy
Time frame: Time 0
Association between response to corticosteroid therapy and some histological criteria
Time frame: Time 0
Evaluate the contribution of histological analysis in etiological diagnosis
Time frame: Time 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Rabant, M.D., PhD principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephritis, Interstitial, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of glomerular filtration rate and renal survival (time frame: Time 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.