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

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study ID
NCT07018622
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cisplatin Nephrotoxicity
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG Oral Tablet — DRUG
    Participants in this arm will receive oral dapagliflozin 10 mg daily starting one day before platinum-based chemotherapy infusion (cisplatin or carboplatin) and continuing for 72 hours. The intervention aims to assess the potential nephroprotective effect of SGLT2 inhibition. Standard supportive care including hydration and magnesium supplementation will be provided to all participants.
  • Placebo Oral Tablet — DRUG
    Participants in this arm will receive a matched oral placebo starting one day before platinum-based chemotherapy infusion (cisplatin or carboplatin) and continuing for 72 hours. Standard supportive care including hydration and magnesium supplementation will also be provided. Investigators and participants will remain blinded to the group assignments.

Study Details

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 patients with solid tumors. Researchers believe that blocking SGLT2 in the kidney may reduce toxicity in the proximal tubules-the area most affected by platinum drugs. The primary goal of this study is to compare the levels of a specific urinary biomarker of kidney injury (called KIM-1) 72 hours after chemotherapy, between patients who receive dapagliflozin and those who receive a placebo. Lower levels of this biomarker may indicate that dapagliflozin is helping protect the kidneys. Secondary goals include comparing additional urinary biomarkers of kidney damage and function-such as EGF (epidermal growth factor), N-acetyl-β-D-glucosaminidase (uNAG), albumin (AlbU), and β2-microglobulin (uβ2-m)-at 72 hours and 7 days after chemotherapy. The study will also assess: The percentage of patients who develop acute kidney injury, Changes in estimated glomerular filtration rate (a measure of kidney function), Electrolyte abnormalities (sodium, magnesium, phosphorus), And any adverse events associated with dapagliflozin use. As exploratory objectives, the trial will also evaluate cancer treatment response between groups (using RECIST 1.1 criteria) and the overall safety and tolerability of dapagliflozin compared to placebo. This is a randomized, double-blind, placebo-controlled clinical trial, meaning that participants will be randomly assigned to receive either dapagliflozin or a placebo, and neither the patients nor the study team will know who receives which treatment until the study ends. The central hypothesis is that dapagliflozin will reduce urinary biomarkers of kidney injury by at least 50% compared to placebo, offering a potential protective strategy against platinum-induced nephrotoxicity without interfering with cancer treatment.

Key Dates

Start date
May 7, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dapagliflozin
    This arm aims to evaluate the potential nephroprotective effect of SGLT2 inhibition using urinary biomarkers of tubular injury.
  • Placebo Comparator: Placebo
    This group serves as a control to evaluate the efficacy and safety of dapagliflozin in preventing platinum-induced nephrotoxicity.

Primary Outcome Measure

Urinary KIM-1/Creatinine (uKIM-1/Cr) expression at 72 hours [ Time Frame: 72 hours (Day 3) after platinum administration ]

Central Contacts

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