kidney injury nephrotoxicity
Conditions
Interventions
Intravenous infusion of 500mL NatriumChloride 0.9%
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age > 18 years Patients must be willing and capable of giving written informed consent Patients with advanced non-squamous cell lung cancer, receiving first line treatment with pemetrexed/pembrolizumab maintenance after carboplatin/pemetrexed/pembrolizumab. ECOG 0-2 Adequate hematological, renal and liver functions.
Exclusion criteria
Exclusion criteria: • Subject with an active auto-immune disease requiring systemic treatment • Lung disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of another steroid) • Previous allogeneic or organ transplant • Known heart failure • Myocardial infarction previous 6 months • Serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator would compromise the patient's ability to complete the study, or would interfere with the evaluation of the efficacy and safety of the study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoints are a decline in kidney function (AKD) based on: eGFR 35 or increase in serum creatinine >50% for | — |
Secondary
| Measure | Time frame |
|---|---|
| TIme to occurence of AKD Rate of decline kidney function (eGFR) Treatment dose intensity, including number of dose reductions | — |
Countries
Netherlands
Outcome results
None listed