Study of Adverse Renal Effects of Immune Checkpoints Inhibitors

NCT ID: NCT03316417

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-27

Study Completion Date

2017-10-27

Brief Summary

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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

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Conditions

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Adverse Effect Renal Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients under 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.

Renal Tolerance to Immunotherapy

Intervention Type OTHER

The main objective is to describe the renal tolerance of these innovative therapies within a population homogeneous of patients.

Interventions

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Renal Tolerance to Immunotherapy

The main objective is to describe the renal tolerance of these innovative therapies within a population homogeneous of patients.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Nephrology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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69HCL17_0475

Identifier Type: -

Identifier Source: org_study_id

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