Study of Adverse Renal Effects of Immune Checkpoints Inhibitors

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316417
• Other study ID #: 69HCL17_0475
• Status: Completed
• Start date: October 27, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Adverse Effect
• Renal Toxicity

Intervention

Other:
• Renal Tolerance to Immunotherapy
The main objective is to describe the renal tolerance of these innovative therapies within a population homogeneous of patients.

Locations

Country	Name	City	State
France	Department of Nephrology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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