Protecting your kidneys during cisplatin or carboplatin chemotherapy

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

This tests whether the diabetes medicine dapagliflozin can protect the kidneys of adults with solid tumors who are receiving cisplatin or carboplatin chemotherapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (other)
• Drugs / interventions: chemotherapy, methotrexate, cyclophosphamide
• Locations: 1 site (México, Tlalpan)
• Trial ID: NCT07018622 on ClinicalTrials.gov

What this trial studies

DAPA-ARMOR is a phase 2, randomized, double-blind, placebo-controlled trial comparing dapagliflozin 10 mg daily to placebo in adults receiving platinum-based chemotherapy for solid tumors. Participants who meet eligibility receive study drug or placebo alongside their planned cisplatin or carboplatin regimens and undergo regular monitoring of kidney function, electrolytes, and biomarkers of proximal tubular injury. The trial measures rates of acute kidney injury, changes in eGFR and electrolyte disturbances, and chemotherapy interruptions or dose reductions related to nephrotoxicity. Key exclusions include very low baseline kidney function, prior SGLT2 inhibitor use, active urinary infection, kidney transplant, or recent nephrectomy.

Who should consider this trial

Good fit: Adults with solid tumors scheduled to receive cisplatin or carboplatin, with ECOG performance 0–2, expected survival >4 months, and eGFR ≥20 ml/min/1.73 m² who are not already on SGLT2 inhibitors and do not have uncontrolled diabetes or active urinary/kidney disorders.

Not a fit: Patients with severely reduced kidney function (eGFR <20 ml/min/1.73 m²), active glomerulopathy, unresolved obstructive uropathy, current use of other nephrotoxic drugs, prior nephrectomy or kidney transplant, or prior SGLT2 inhibitor exposure are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, dapagliflozin could reduce platinum-induced kidney injury and help patients complete planned chemotherapy without dose reductions or delays.

How similar studies have performed: SGLT2 inhibitors have shown renal-protective effects in diabetic and non-diabetic chronic kidney disease, but their use specifically to prevent platinum-induced nephrotoxicity is largely novel with limited clinical data.

Eligibility criteria

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 genitourinary infections

Where this trial is running

México, Tlalpan

• Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" — México, Tlalpan, Mexico (RECRUITING)

Study contacts

• Principal investigator: Juan M Mejía-Vilet, PhD — Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Study coordinator: Erick Y Zuñiga, MD

Conditions: Solid Tumors, Cisplatin Nephrotoxicity, Platinum-Based Chemotherapy, Cisplatin, Carboplatin, Nephrotoxicity, Kidney Tubules, Proximal, SGLT2 Inhibitors