Effect of Sodium-Glucose Cotransporter 2 Inhibition on Urinary Biomarkers of Kidney Injury After Platinum-Based Chemotherapy

What this Trial Is About

Patients with solid tumors who receive platinum-based chemotherapy often face the risk of kidney damage caused by these drugs. This damage can lead to delays or changes in cancer treatment and worsen patient health. Currently, there are no highly effective ways to prevent this kidney injury. This study explores whether dapagliflozin, a medication known as a Sodium-Glucose Cotransporter 2 (SGLT2) inhibitor, can protect the kidney's proximal tubules from this damage during chemotherapy. The trial is a randomized, double-blind, placebo-controlled Phase 2 study assessing this potential protection. Participants will be randomly assigned to receive either oral dapagliflozin 10 mg or a placebo, starting one day before their platinum-based chemotherapy and continuing for 72 hours. All patients will receive standard supportive care including hydration and magnesium supplements. The study will measure different urinary biomarkers of kidney injury, including Kidney Injury Molecule-1 (KIM-1), epidermal growth factor, and others, at 72 hours and seven days after chemotherapy. Researchers will also monitor kidney function, electrolyte levels, adverse events, and cancer treatment response. Throughout the study, participants will provide urine and blood samples at specified times for biomarker and lab analysis. Kidney injury markers will be compared between the dapagliflozin and placebo groups to evaluate potential kidney protection. Safety and tolerability of dapagliflozin will be assessed during chemotherapy and up to four weeks afterward. The study aims to provide evidence that dapagliflozin may reduce kidney damage without affecting cancer treatment outcomes, with total participation lasting several weeks.

Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity