Solid TumorsPhase 2DAPA-ARMORNCT07018622
Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity
A Phase 2 study testing Dapagliflozin 10 MG Oral Tablet in people with Solid Tumors and Cisplatin Nephrotoxicity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Cisplatin Nephrotoxicity
- What is being tested?
- Dapagliflozin 10 MG Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteMexico
- Study dates
- 7 May 2025to 30 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
México, Tlalpan, 14080
About this study
Official title: Effect of Sodium-Glucose Cotransporter 2 Inhibition on Urinary Biomarkers of Kidney Injury After Platinum-Based Chemotherapy
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.
Read more
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.
Read the detailed description
Platinum-based chemotherapy agents such as cisplatin and carboplatin are widely used in the treatment of various solid tumors due to their efficacy. However, their clinical utility is frequently limited by nephrotoxicity, predominantly targeting the proximal tubular epithelium. This can lead to acute kidney injury (AKI), electrolyte imbalances (notably hypomagnesemia, hyponatremia, and hypophosphatemia), and progression to chronic kidney disease (CKD). Current preventive strategies are largely supportive and include aggressive hydration, mannitol-induced diuresis, and magnesium supplementation, none of which offer specific cellular protection.
Recent evidence suggests that inhibitors of the sodium-glucose cotransporter type 2 (SGLT2 inhibitors or iSGLT2s), such as dapagliflozin, may confer renal protective effects beyond their original indication for type 2 diabetes mellitus. Mechanistically, SGLT2 inhibition reduces proximal tubular reabsorption of sodium and glucose, leading to improved tubular oxygenation and reduced inflammatory and oxidative stress signaling. This has been associated with reduced progression of CKD and favorable modulation of tubular injury markers in both diabetic and non-diabetic populations.
The present study, DAPA-ARMOR, is a randomized, double-blind, placebo-controlled clinical trial designed to assess the nephroprotective effects of dapagliflozin in adult patients with solid tumors undergoing platinum-based chemotherapy. The hypothesis is that short-term prophylactic administration of dapagliflozin can reduce proximal tubular injury, as evidenced by changes in urinary biomarkers.
The primary endpoint is the difference in urinary levels of Kidney Injury Molecule-1 (KIM-1) 72 hours after platinum administration, between the intervention (dapagliflozin) and control (placebo) arms.
Secondary endpoints include changes in additional urinary biomarkers associated with tubular injury and repair:
uEGF (urinary Epidermal Growth Factor) uNAG (N-acetyl-β-D-glucosaminidase) uAlb (urinary albumin) uβ2-microglobulin These biomarkers will be measured at baseline, 72 hours (±3 days), and 168 hours (±7 days) after chemotherapy administration.
Additional secondary endpoints include:
Incidence of AKI at 72 hours and 7 days post-chemotherapy (defined per KDIGO criteria), Changes in estimated glomerular filtration rate (eGFR) using the CKD-EPI 2021 equation (Cystatin C and creatinine-based), Incidence of chemotherapy-related electrolyte disturbances (Na, Mg, P), Frequency and severity of adverse events graded according to the CTCAE (Common Terminology Criteria for Adverse Events).
Exploratory outcomes will assess:
Cancer response rate using RECIST 1.1 criteria at the first post-randomization imaging evaluation, Tolerability of dapagliflozin during chemotherapy. The study drug (dapagliflozin) or placebo will be administered starting 24 hours prior to platinum chemotherapy and continued for a total of 4 days, covering the period of expected peak tubular exposure and injury.
Participants will be stratified by type of platinum agent used. Urine and blood samples will be collected at pre-specified timepoints for biomarker analysis and laboratory monitoring.
The study design aims to ensure high internal validity while capturing clinically relevant endpoints that could inform future strategies to mitigate chemotherapy-induced nephrotoxicity without compromising oncologic efficacy.
- Conditions
- Solid Tumors, Cisplatin Nephrotoxicity
- Being tested
- Dapagliflozin 10 MG Oral Tablet, Placebo Oral Tablet
- Keywords
- Solid Tumors, Platinum-Based Chemotherapy, Cisplatin, Carboplatin, Nephrotoxicity, Kidney Tubules, Proximal, SGLT2 Inhibitors, Kidney Injury Molecule-1, Renal Protection, Chemotherapy-Induced Kidney Injury, Randomized Controlled Trial, Urinary Biomarkers, Dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MG Oral TabletDrug
Also called Forxiga, AZD2281
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 TabletDrug
Also called Matching placebo
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 group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | This arm aims to evaluate the potential nephroprotective effect of SGLT2 inhibition using urinary biomarkers of tubular injury. Receives: Drug: Dapagliflozin 10 MG Oral Tablet |
| Placebo | Placebo comparator | This group serves as a control to evaluate the efficacy and safety of dapagliflozin in preventing platinum-induced nephrotoxicity. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary KIM-1/Creatinine (uKIM-1/Cr) expression at 72 hours
Measurement of urinary KIM-1 normalized to creatinine (uKIM-1/Cr [pg/mg]) to evaluate renal tubular injury at 72 hours after platinum-based chemotherapy, comparing dapagliflozin vs. placebo.
Measured: 72 hours (Day 3) after platinum administration
Secondary outcomes (8)
Urinary Epidermal Growth Factor levels adjusted by creatinine (EGF/Cr)
Quantification of urinary EGF concentration adjusted by urinary creatinine (uEGF/Cr [ng/mg Cr]) as a marker of tubular function at 0, 72 hours (Day 3) and 168 hours (Day 7) following platinum-based chemotherapy. The analysis will compare mean absolute values and changes from baseline between the dapagliflozin and placebo groups.
Measured: Baseline to Day 3 and Day 7
Urinary N-acetyl-β-D-glucosaminidase levels adjusted by creatinine (uNAG/Cr)
Measurement of urinary uNAG activity adjusted by urinary creatinine (uNAG/Cr [U/g]) to assess proximal tubular injury at 72 hours (Day 3) and 168 hours (Day 7) following platinum-based chemotherapy. The analysis will compare mean absolute values and changes from baseline between the dapagliflozin and placebo groups.
Measured: Baseline to Day 3 and Day 7
Urinary Albumin levels adjusted by creatinine (AlbU/Cr)
Determination of urinary albumin excretion adjusted by urinary creatinine (AlbU/Cr [mg/g]) as an indicator of glomerular and tubular dysfunction at 72 hours (Day 3) and 168 hours (Day 7) post-chemotherapy. The analysis will compare mean absolute values and changes from baseline between the dapagliflozin and placebo groups.
Measured: Baseline to Day 3 and Day 7
Urinary β2-microglobulin levels adjusted by creatinine (uβ2-m/Cr)
Assessment of urinary β2-microglobulin concentration adjusted by urinary creatinine (uβ2-m/Cr [mg/g]) to evaluate proximal tubular injury at 72 hours (Day 3) and 168 hours (Day 7) following platinum-based chemotherapy. The analysis will compare mean absolute values and changes from baseline between the dapagliflozin and placebo groups.
Measured: Baseline to Day 3 and Day 7
Urinary Kidney Injury Molecule-1 levels adjusted by creatinine (KIM-1/Cr)
Quantification of urinary KIM-1 concentration adjusted by urinary creatinine (uKIM-1/Cr [pg/mg]) as a biomarker of renal tubular injury at baseline (pre-chemotherapy), and 168 hours (Day 7) following platinum-based chemotherapy. The analysis will compare mean absolute values and changes from baseline between the dapagliflozin and placebo groups.
Measured: Baseline to day 7 after platinum administration
Incidence of Acute Kidney Injury (AKI) at 72 hours and Day 7
Comparison of the proportion of participants developing acute kidney injury (AKI) [KDIGO criteria] at 72 hours and 7 days post-platinum chemotherapy with and without dapagliflozin.
Measured: Baseline to Day 3 and Day 7
Estimated Glomerular Filtration Rate (eGFR) at 72 hours and Day 7
Comparison of the estimated glomerular filtration rate (eGFR) (using CysC-Cr CKD-EPI 2021 formula) at 72 hours and 7 days after platinum chemotherapy, with and without dapagliflozin.
Measured: 72 hours (Day 3), 168 hours (Day 7) after platinum administration
Safety and tolerability of dapagliflozin in patients with solid tumors receiving platinum-based chemotherapy
Monitoring and comparison of adverse events as graded by CTCAE v5.0, with a focus on severity including withdrawal or dose interruption, comparing dapagliflozin vs. placebo.
Measured: From first dose of study drug through 4 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start7 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan M Mejía-Vilet, PhD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018622
- Sponsor's protocol ID
- NMM-5274
- Acronym
- DAPA-ARMOR
- Status last verified
- Mar 2026
- First submitted
- 26 May 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mathavan A, Mathavan A, Shah CV. Beneficial Effects of Sodium-Glucose Cotransporter 2 Inhibitors in Cisplatin Nephrotoxicity: A Mechanistic Review. Kidney360. 2026 May 1;7(5):1150-1159. doi: 10.34067/KID.0000001194. Epub 2026 Mar 19.
PubMed 41854743
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium-Glucose Cotransporter 2 Inhibition on Urinary Biomarkers of Kidney Injury After Platinum-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT07018622
- Acronym / sponsor ID
- DAPA-ARMOR / NMM-5274
- Conditions
- Solid Tumors, Cisplatin Nephrotoxicity
- Keywords
- Solid Tumors, Platinum-Based Chemotherapy, Cisplatin, Carboplatin, Nephrotoxicity, Kidney Tubules, Proximal, SGLT2 Inhibitors, Kidney Injury Molecule-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Platinum-based chemotherapy agents such as cisplatin and carboplatin are widely used in the treatment of various solid tumors due to their efficacy. However, their clinical utility is frequently limited by nephrotoxicity, predominantly targeting the proximal tubular epithelium. This can lead to acute kidney injury (AKI), electrolyte imbalances (notably hypomagnesemia, hyponatremia, and hypophosphatemia), and progression to chronic kidney disease (CKD). Current preventive strategies are largely supportive and include aggressive hydration, mannitol-induced diuresis, and magnesium supplementation, none of which offer specific cellular protection.
Recent evidence suggests that inhibitors of the sodium-glucose cotransporter type 2 (SGLT2 inhibitors or iSGLT2s), such as dapagliflozin, may confer renal protective effects beyond their original indication for type 2 diabetes mellitus. Mechanistically, SGLT2 inhibition reduces proximal tubular reabsorption of sodium and glucose, leading to improved tubular oxygenation and reduced inflammatory and oxidative stress signaling. This has been associated with reduced progression of CKD and favorable modulation of tubular injury markers in both diabetic and non-diabetic populations.
The present study, DAPA-ARMOR, is a randomized, double-blind, placebo-controlled clinical trial designed to assess the nephroprotective effects of dapagliflozin in adult patients with solid tumors undergoing platinum-based chemotherapy. The hypothesis is that short-term prophylactic administration of dapagliflozin can reduce proximal tubular injury, as evidenced by changes in urinary biomarkers.
The primary endpoint is the difference in urinary levels of Kidney Injury Molecule-1 (KIM-1) 72 hours after platinum administration, between the intervention (dapagliflozin) and control (placebo) arms.
Secondary endpoints include changes in additional urinary biomarkers associated with tubular injury and repair:
uEGF (urinary Epidermal Growth Factor) uNAG (N-acetyl-β-D-glucosaminidase) uAlb (urinary albumin) uβ2-microglobulin These biomarkers will be measured at baseline, 72 hours (±3 days), and 168 hours (±7 days) after chemotherapy administration.
Additional secondary endpoints include:
Incidence of AKI at 72 hours and 7 days post-chemotherapy (defined per KDIGO criteria), Changes in estimated glomerular filtration rate (eGFR) using the CKD-EPI 2021 equation (Cystatin C and creatinine-based), Incidence of chemotherapy-related electrolyte disturbances (Na, Mg, P), Frequency and severity of adverse events graded according to the CTCAE (Common Terminology Criteria for Adverse Events).
Exploratory outcomes will assess:
Cancer response rate using RECIST 1.1 criteria at the first post-randomization imaging evaluation, Tolerability of dapagliflozin during chemotherapy. The study drug (dapagliflozin) or placebo will be administered starting 24 hours prior to platinum chemotherapy and continued for a total of 4 days, covering the period of expected peak tubular exposure and injury.
Participants will be stratified by type of platinum agent used. Urine and blood samples will be collected at pre-specified timepoints for biomarker analysis and laboratory monitoring.
The study design aims to ensure high internal validity while capturing clinically relevant endpoints that could inform future strategies to mitigate chemotherapy-induced nephrotoxicity without compromising oncologic efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10 MG Oral TabletThis arm aims to evaluate the potential nephroprotective effect of SGLT2 inhibition using urinary biomarkers of tubular injury. |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletThis group serves as a control to evaluate the efficacy and safety of dapagliflozin in preventing platinum-induced nephrotoxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 MG Oral TabletAlso: Forxiga, AZD2281Participants 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. | Drug | Dapagliflozin |
| Placebo Oral TabletAlso: Matching placeboParticipants 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. | Drug | Placebo |
Primary outcome
Urinary KIM-1/Creatinine (uKIM-1/Cr) expression at 72 hours
Time frame: 72 hours (Day 3) after platinum administration
Measurement of urinary KIM-1 normalized to creatinine (uKIM-1/Cr [pg/mg]) to evaluate renal tubular injury at 72 hours after platinum-based chemotherapy, comparing dapagliflozin vs. placebo.
8 secondary outcomes
Urinary Epidermal Growth Factor levels adjusted by creatinine (EGF/Cr)
Time frame: Baseline to Day 3 and Day 7
Urinary N-acetyl-β-D-glucosaminidase levels adjusted by creatinine (uNAG/Cr)
Time frame: Baseline to Day 3 and Day 7
Urinary Albumin levels adjusted by creatinine (AlbU/Cr)
Time frame: Baseline to Day 3 and Day 7
Urinary β2-microglobulin levels adjusted by creatinine (uβ2-m/Cr)
Time frame: Baseline to Day 3 and Day 7
Urinary Kidney Injury Molecule-1 levels adjusted by creatinine (KIM-1/Cr)
Time frame: Baseline to day 7 after platinum administration
Incidence of Acute Kidney Injury (AKI) at 72 hours and Day 7
Time frame: Baseline to Day 3 and Day 7
Estimated Glomerular Filtration Rate (eGFR) at 72 hours and Day 7
Time frame: 72 hours (Day 3), 168 hours (Day 7) after platinum administration
Safety and tolerability of dapagliflozin in patients with solid tumors receiving platinum-based chemotherapy
Time frame: From first dose of study drug through 4 weeks of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 41854743Mathavan A, Mathavan A, Shah CV. Beneficial Effects of Sodium-Glucose Cotransporter 2 Inhibitors in Cisplatin Nephrotoxicity: A Mechanistic Review. Kidney360. 2026 May 1;7(5):1150-1159. doi: 10.34067/KID.0000001194. Epub 2026 Mar 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan M Mejía-Vilet, PhD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10 MG Oral Tablet in people with Solid Tumors and Cisplatin Nephrotoxicity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erick Y Zuñiga, MD (+ 52 55 5487 0900 ext. 4142, erick.zunigag@incmnsz.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary KIM-1/Creatinine (uKIM-1/Cr) expression at 72 hours (time frame: 72 hours (Day 3) after platinum administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07018622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.