TerminatedNot Applicable

Retrospective Study on the Safety of Nivolumab in Patients With mRCC and Renal Failure

Stopped: Healted Prematurely

Italy81 participantsStarted 2020-06-29

Plain-language summary

This is an observational, retrospective, multicenter study aimed to compare the toxicity of Nivolumab in patients with metastatic renal cell carcinoma treated in line II and III stratified into 3 patient groups: * patients with normal or mildly reduced renal function (GFR\<90 and ≥60 ml/min/1.73 m\^2); * patients with moderate renal impairment (GFR \<60 e ≥30 ml/min/1.73 m\^2), * patients with severe renal impairment (GFR \<30 e ≥15 ml/min/1.73 m\^2) Patients must have been treated with Nivolumab, as per clinical practice. All patients who have received at least one drug administration between february 2017 to December 31, 2018 will be enrolled in the study.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * signing informed consent, in case of patients still alive; * histologically confirmed diagnosis of metastatic renal cell carcinoma; * at least one administration of Nivolumab therapy, in the second-or third line of treatment february 2017 to December 31, 2018; * availability of inpatient and/or outpatient medical records for clinical data collection. Exclusion Criteria: * patients who have received immunotherapy under EAP (Expanded Access Programm) or other clinical trials; * dialysis patients.

What they're measuring

Incidence of Treatment-emergent Adverse Events

Timeframe: At study completion (up to 16 months)

Trial details

NCT IDNCT07117409

SponsorAzienda USL Reggio Emilia - IRCCS

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2022-05-30

View on ClinicalTrials.gov More Metastatic Renal Cell Carcinoma trials