Study of Adverse Renal Effects of Immune Checkpoints Inhibitors

Completed

• Conditions: Adverse Effect; Renal Toxicity
• Interventions: Other: Renal Tolerance to Immunotherapy

• Registration Number: NCT03316417
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-20
• Study Start: 2017-10-27
• Primary Completion: 2017-10-27
• Study Completion: 2017-10-27
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients under immunotherapy	Renal Tolerance to Immunotherapy	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Acute kidney Injury	maximum 6 months	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.

Trial Locations

Locations (1)

Department of Nephrology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France