Study of Adverse Renal Effects of Immune Checkpoints Inhibitors (ImmuNoTox(INT))

Civil Hospices of Lyon

Status: Completed

Conditions: Adverse Effect; Renal Toxicity

Treatments: Other: Renal Tolerance to Immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03316417

69HCL17_0475

Details and patient eligibility

About

Renal toxic events related to Immune Checkpoints Inhibitors therapy (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) have been recently reported. These were immune-allergic acute interstitial nephritis.

However, no systematic study has ever focused on renal adverse effects. The investigators study here the evolution of renal function and the occurrence of nephrological events in a large monocentric cohort of patients treated with Immune Checkpoints Inhibitors in the Centre Hospitalier Lyon Sud. Nephrological parameters based on Serum Creatinine (SCr), estimate Glomerular Filtration Rate (eGFR) and urinary sediment are monitored. The aim of the study is to determine the incidence of renal events due to Immune Checkpoint Inhibitor treatment, particularly Acute Kidney Injury, (AKI) and identify the clinical presentation, histological description and risk factors.

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients treated by one of the Immune Checkpoints inhibitors (Nivolumab, Pembrolizumab, ipilimumab or Atezolizumab), for neoplastic pathology in dermatologic, pneumologic, or medical oncology department.

Exclusion criteria

• Minor patients (less than 18y).
• Refusal to consent.
• For statistical analysis: Acute Renal Failure caused by another identified etiology than drug toxicity.

Trial design

353 participants in 1 patient group

Patients under immunotherapy

Description:

All patients with Immune Checkpoints inhibitors treatment (Nivolumab, Pembrolizumab, ipilimumab, Atezolizumab), for dermatologic, pneumologic, or oncologic cancer treated on Centre Hospitalier Lyon Sud are included.

Treatment:

Other: Renal Tolerance to Immunotherapy