Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity
Patients with cancer who receive platinum-based chemotherapy are at increased risk of kidney injury caused by these drugs. This form of toxicity can lead to treatment delays, dose reductions, or permanent discontinuation of chemotherapy, all of which can negatively impact cancer outcomes and increase patient morbidity.
| Condition(s) | Solid Tumors, Cisplatin Nephrotoxicity |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Patients with cancer who receive platinum-based chemotherapy are at increased risk of kidney injury caused by these drugs. This form of toxicity can lead to treatment delays, dose reductions, or permanent discontinuation of chemotherapy, all of which can negatively impact cancer outcomes and increase patient morbidity. Despite the clinical significance, there are currently no effective strategies to prevent platinum-induced kidney damage. Existing preventive measures-such as hydration, mannitol use, and magnesium supplementation-are limited and not always effective. This clinical trial investigates whether a type of medication known as a Sodium-Glucose Cotransporter 2 (SGLT2) inhibitor, specifically dapagliflozin, can protect the kidneys from damage during platinum-based chemotherapy in pa |
| Who can participate | Inclusion Criteria: * Signed informed consent form * Diagnosis of a solid tumor requiring a platinum-based chemotherapy regimen (cisplatin or carboplatin) * Expected survival \> 4 months * ECOG performance status 0-2 Exclusion Criteria: * History of nephrectomy * History of kidney transplant * Concurrent use of known nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, cyclophosphamide, ifosfamide, methotrexate) * Type 1 diabetes mellitus * Poorly controlled type 2 diabetes (HbA1c \> 8% or fasting glucose \> 200 mg/dL in the past month) * Active glomerulopathy * Prior use of SGLT2 inhibitors or current indication for their use * eGFR \< 20 ml/min/1.73 m² * Active urinary tract infection * Unresolved obstructive uropathy * Participation in another clinical trial * History of recurrent |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Locations | México, Tlalpan, Mexico |
| Start date | 2025-05-07 |
| NCT ID | NCT07018622 |
| Official listing | https://clinicaltrials.gov/study/NCT07018622 |