Acute Interstitial Nephritis Clinical Trial
— IDENIAMOfficial title:
Identification of the Causative Drug in Drug-induced Acute Interstitial Nephritis
Drug-induced acute interstitial nephritis (DAIN) is a rare entity characterized by acute renal failure linked to inflammation of the renal parenchyma secondary to allergenic drug exposure. Treatment is based primarily on the precise identification of the causative drug and its final elimination. Currently, the identification of the causative drug is based on clinical presumption. There is no test to formally identify the causative drug. On the other hand, in-vitro allergological tests (lymphocyte transformation test in particular) have been developed in the course of immuno-allergic drug toxiderma linked to delayed type IV hypersensitivity to identify the causal drug. These tests have not been studied during DAIN, but their value in drug-induced eruption is indisputable. The objective of our study is to determine whether in vitro allergy tests can identify the causative drug during DAIN. If the in vitro tests fail, they will be supplemented by allergological skin tests.
Status | Not yet recruiting |
Enrollment | 44 |
Est. completion date | January 2024 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - Acute renal failure with an eGFR < 60 ml/min/1.73m2 by CKD-EPI managed in the participating centers in the study - Histologically proven DAIN by renal biopsy (anatomopathological reading in each center according to local habits): presence of an infiltration of inflammatory cells (lymphocytes, monocytes, plasmocytes, eosinophils) in the interstitium accompanied by a variable degree of interstitial edema and fibrosis - Successful diagnosis of DAIN with identification of one or more attributable drugs - Signed consent - Membership in a social security plan or entitled person Exclusion Criteria: - Anatomic-clinical suspicion of AIN of infectious or autoimmune cause or associated with systemic diseases (Sjögren's syndrome, sarcoidosis, tubulointerstitial nephritis syndrome and uveitis, systemic lupus, IgG4-associated disease) - Kidney transplant patients - Current immunosuppressive treatment at the time of allergological testing (test results not interpretable) - Participation in other interventional research - Patient under state medical assistance - Patient deprived of liberty or under legal protection - Pregnancy |
Country | Name | City | State |
---|---|---|---|
France | Nephrology department, Tenon hospital - APHP | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with at least one allergological test (in vitro or in vivo) positive for a suspected molecule | In vitro tests are lymphocyte transformation test, ELISPOT-Interferon gamma, measurement of CD154 expression. In vivo (skin) tests are patch test, prick test, intradermal test | 6 months | |
Secondary | Proportion of patients with at least one positive result in one of the three in vitro allergological tests | Proportion of patients with at least one positive result in one of the three in vitro allergological tests performed 3-18 months after an episode of histologically confirmed AMN | 6 months | |
Secondary | Proportion of patients with positive results for each in vitro allergy test performed 3-18 months after an episode of histologically confirmed NIAM | 6 months | ||
Secondary | Proportion of patients with a positive result for one of the three skin tests in case of negative in vitro test | 6 months | ||
Secondary | Proportion of patients with positive results for each skin test in case of negative in vitro tests | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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