ImmuNoTox(INT)
Adverse Renal Effects of Immune Checkpoints Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) in Clinical Practice: a Large Monocentric Prospective Study
Sponsor study identifier
observational
353
1 country
1
Study Start
October 27, 2017
Actual (reported)Primary Completion
October 27, 2017
Actual (reported)Study Completion
October 27, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 27, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2017
Actual (reported)October 20, 2017
Actual (reported)October 27, 2017
Actual (reported)October 27, 2017
Actual (reported)October 27, 2017
Actual (reported)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
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.
The main objective is to describe the renal tolerance of these innovative therapies within a population homogeneous of patients.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Department of Nephrology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495, France
353 participants (actual enrollment reported by the registry).
First Submitted
October 17, 2017
First Posted
October 20, 2017
Study Start
October 27, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 27, 2017
Actual (reported)Study Completion
October 27, 2017
Actual (reported)Last Updated
August 14, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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