Adverse Effect Clinical Trial
— ImmuNoTox(INT)Official title:
Adverse Renal Effects of Immune Checkpoints Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) in Clinical Practice: a Large Monocentric Prospective Study
Verified date | August 2019 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 353 |
Est. completion date | October 27, 2017 |
Est. primary completion date | October 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Department of Nephrology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon | Pierre-Bénite |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Acute kidney Injury | Acute kidney Injury is defined by the KDIGO (Kidney Disease: Improving Global Outcomes) recommendations by an increase in serum creatinine during follow-up of at least 1.5 times the baseline. Follow-up : Nephrological parameters will be notice during whole treatment duration, until interruption for medical reason (tumoral progression, severe adverse event) or end of the study (stop of the collection and analysis of the results); In this case, a 6-month follow-up period for patients undergoing treatment at the time of the collection of data. |
maximum 6 months |
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