Study of Adverse Renal Effects of Immune Checkpoints Inhibitors

NCT03316417 | Completed

• 1 other identifier: 69HCL17_0475
• Study Type: observational
• Target: 353
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Effect; Renal Toxicity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: Renal Tolerance to Immunotherapy

Interventions

Renal Tolerance to Immunotherapy OTHER

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

Patients under immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Pierre-Bénite, 69495, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 20, 2017
• Study Start: October 27, 2017
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)