Chronic Kidney Disease (Mild to Moderate)Phase 4IECA-MEXNCT07405216
Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease
A Phase 4 study testing Dapagliflozin (10mg Tab) in people with Chronic Kidney Disease (Mild to Moderate) and Albuminuria, run by Centenario Hospital Miguel Hidalgo at 1 site in Mexico.
Trial summary
Chronic kidney disease (CKD) is highly prevalent in the state of Aguascalientes, Mexico, particularly among adolescents and young adults. Epidemiologic and histologic studies suggest that this burden is largely driven by reduced nephron endowment of prenatal origin, leading to compensatory glomerular hyperfiltration… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Chronic Kidney Disease (Mild to Moderate), Albuminuria, Adolescent
- What is being tested?
- Dapagliflozin (10mg Tab)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- 23 Apr 2026to 30 Oct 2027
- Phase
- Phase 4
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Residence in Aguascalientes
- Persistent albuminuria (ACR >30 and <300 mg/g)
- Estimated glomerular filtration rate ≥60 mL/min/1.73 m²
- No identifiable secondary cause (e.g., lupus, diabetes mellitus)
- Renal biopsy showing adaptive podocytopathy or perihilar focal segmental glomerulosclerosis -
Who cannot join
- Hypoalbuminemia
- Nephrotic syndrome
- Persistent macroalbuminuria (ACR >300 mg/g)
- Secondary causes of CKD, including congenital anomalies of the kidney and urinary tract or polycystic kidney disease -
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 de atención Integral de Enfermedades Renales del Estado de Aguascalientes
Aguascalientes, Aguascalientes, 20000
About this study
Official title: Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Persistent Albuminuria: A Randomized Controlled Clinical Trial
Chronic kidney disease (CKD) is highly prevalent in the state of Aguascalientes, Mexico, particularly among adolescents and young adults. Epidemiologic and histologic studies suggest that this burden is largely driven by reduced nephron endowment of prenatal origin, leading to compensatory glomerular hyperfiltration, adaptive podocytopathy, and persistent albuminuria at early stages of disease.
Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have demonstrated nephroprotective effects in adult populations with CKD, including reductions in albuminuria and slowing of disease progression, independent of diabetes status. However, no randomized controlled trials have evaluated the efficacy and safety of SGLT2 inhibitors in adolescents with early-stage CKD and persistent albuminuria.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether treatment with an SGLT2 inhibitor reduces albuminuria in adolescents aged 14 to 18 years with persistent microalbuminuria (albumin-to-creatinine ratio 30-300 mg/g) and preserved kidney function. Participants will be randomized in a 2:1 ratio to receive dapagliflozin 10 mg daily or placebo for six months. The primary outcome is the change in urinary albumin-to-creatinine ratio from baseline to six months. Secondary outcomes include changes in estimated glomerular filtration rate and safety outcomes.
Read the detailed description
Chronic kidney disease (CKD) is a major global health problem and represents one of the fastest-growing causes of mortality worldwide. In the state of Aguascalientes, Mexico, CKD prevalence is among the highest reported globally, with an unusually high burden affecting adolescents and young adults.
Statewide screening programs and renal biopsy registries have identified a distinct epidemiologic and histologic pattern in this region. Adolescents with early-stage CKD frequently present with persistent albuminuria, glomerulomegaly, absence of interstitial fibrosis, and adaptive podocytopathy, findings consistent with reduced nephron endowment of prenatal origin. Over time, these lesions may progress to adaptive focal segmental glomerulosclerosis and clinically significant CKD in young adulthood. The predominant pathogenic mechanism in this population is believed to be glomerular hyperfiltration.
Pharmacologic therapies targeting hyperfiltration have proven efficacy in slowing CKD progression. Renin-angiotensin-aldosterone system inhibitors are standard of care, and more recently, sodium-glucose cotransporter-2 inhibitors have demonstrated substantial nephroprotective effects in adult populations, including patients without diabetes and across a wide range of albuminuria levels. Despite this evidence, adolescents and patients with early-stage CKD (G1-G2 A2) have been systematically excluded from major randomized trials.
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of an SGLT2 inhibitor in adolescents with persistent albuminuria and preserved kidney function. Eligible participants are adolescents aged 14 to 18 years residing in Aguascalientes with persistent microalbuminuria (albumin-to-creatinine ratio 30-300 mg/g), estimated glomerular filtration rate ≥60 mL/min/1.73 m², and no identifiable secondary cause of kidney disease.
After screening and baseline evaluation-including medical history, laboratory testing, immunologic studies, and renal ultrasound-eligible participants will be randomized in a 2:1 ratio to receive dapagliflozin 10 mg daily or matching placebo for a total duration of six months. All participants will receive standardized nutritional counseling.
Follow-up visits will occur every two months and will include clinical assessment, physical examination, blood pressure measurement, and laboratory testing. Urinary albumin-to-creatinine ratio will be measured using standardized laboratory methods.
The primary endpoint is the change in urinary albumin-to-creatinine ratio from baseline to six months, analyzed using log-transformed values. Secondary endpoints include changes in estimated glomerular filtration rate and assessment of safety outcomes, including adverse events such as hypotension and urinary tract infections.
This trial seeks to generate high-quality evidence on the efficacy and safety of SGLT2 inhibitors in adolescents with early-stage CKD, a population with a disproportionate disease burden and limited therapeutic evidence.
- Conditions
- Chronic Kidney Disease (Mild to Moderate), Albuminuria, Adolescent, Sodium Glucose Co-Transporter 2 Inhibitors
- Being tested
- Dapagliflozin (10mg Tab), Placebo
- Keywords
- Chronic kidney disease, Persistent albuminuria, sodium glucose co-transporter 2 inhibitors
- Medical subject headings
- Renal Insufficiency, Chronic, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (10mg Tab)Drug
Dapagliflozin 10 mg daily
PlaceboDrug
Placebo 10 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Adolescents with persistent albuminuria Receives: Drug: Dapagliflozin (10mg Tab) |
| Placebo | Placebo comparator | Placebo 10 mg daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Albuminuria
The urinary albumin-to-creatinine ratio (ACR) will be calculated. The primary endpoint will be the log-transformed difference between baseline and six-month ACR. Absolute and relative (% reduction) changes in ACR will also be reported.
Measured: 2, 4 and 6 months
Secondary outcomes (1)
Glomerular filtration rate
Glomerular filtration rate estimated with Chronic Kidney Disease in Children under (age) 25 (CKiD U25) equation
Measured: 2,4 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start23 Apr 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (Mild to Moderate)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centenario Hospital Miguel Hidalgo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405216
- Sponsor's protocol ID
- INAER2026-1
- Acronym
- IECA-MEX
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.
PubMed 40470996Kanbay M, Copur S, Bakir CN, Covic A, Ortiz A, Tuttle KR. Glomerular hyperfiltration as a therapeutic target for CKD. Nephrol Dial Transplant. 2024 Jul 31;39(8):1228-1238. doi: 10.1093/ndt/gfae027.
PubMed 38308513Staplin N, Roddick AJ, Neuen BL, Anker SD, Bhatt DL, Butler J, Cherney DZ, Docherty KF, Fletcher RA, Inzucchi SE, Jardine M, Mahaffey KW, McGuire DK, McMurray JJV, Neal B, Packer M, Patel SM, Perkovic V, Sabatine MS, Solomon S, Vaduganathan M, Wanner C, Wheeler DC, Zannad F, Haynes R, Heerspink HJL, Herrington WG; SGLT2 Inhibitor Meta-Analysis Cardio-Renal Trialists' Consortium (SMART-C). Effects of Sodium Glucose Cotransporter 2 Inhibitors by Diabetes Status and Level of Albuminuria: A Meta-Analysis. JAMA. 2026 Jan 20;335(3):220-232. doi: 10.1001/jama.2025.20835.
PubMed 41202026Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
PubMed 32970396The EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Mayne KJ, Ng SYA, Sammons E, Zhu D, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney D, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Petrini M, Massey D, Eilbracht J, Brueckmann M, Landray MJ, Baigent C, Haynes R. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan 12;388(2):117-127. doi: 10.1056/NEJMoa2204233. Epub 2022 Nov 4.
PubMed 36331190Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
PubMed 38490803Ortiz A, Arreola Guerra JM, Chan JCN, Jha V, Kramer H, Nicholas SB, Pavkov ME, Wanner C, Wong LP, Cheung M, King JM, Grams ME, Jadoul M, Tuttle KR; Conference Participants. Preventing chronic kidney disease and maintaining kidney health: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 2025 Oct;108(4):555-571. doi: 10.1016/j.kint.2025.04.005. Epub 2025 Jun 19.
PubMed 40536455Alcalde-Ortiz ML, Jaramillo-Arriaga F, Ibarra-Orenday D, Gonzalez-Dominguez SI, Calzada-Gallegos HD, Pinales-Jimenez AA, Carrillo-Aguilera IA, Flota-Marin DA, Collazo-Zamores MG, Aguirre-Moreno PD, Gutierrez-Hernandez SD, Del Toro-Delgado V, Delgadillo-Castaneda R, Sanchez-Ortiz MDR, Sanchez-Gonzalez I, Ramos-Medellin CL, Chew-Wong A, Macias-Diaz DM, Arreola-Guerra JM. Pediatric kidney dimensions and risk of persistent albuminuria in Mexican adolescents. Kidney Int. 2024 Apr;105(4):824-834. doi: 10.1016/j.kint.2023.11.034. Epub 2024 Jan 25.
PubMed 38280517Macias Diaz DM, Corrales Aguirre MDC, Reza Escalera AL, Tiscareno Gutierrez MT, Ovalle Robles I, Macias Guzman MJ, Garcia Diaz AL, Gutierrez Pena MC, Alvarado-Najera AN, Gonzalez Dominguez I, Villavicencio-Bautista JC, Herrera Rodriguez AA, Marin-Garcia R, Avelar Gonzalez FJ, Wong AC, Galvan Guerra E, Delgadillo Castaneda R, Prado Aguilar CA, Zuniga-Macias LP, Arreola Guerra JM. Histologic characterization and risk factors for persistent albuminuria in adolescents in a region of highly prevalent end-stage renal failure of unknown origin. Clin Kidney J. 2022 Jan 14;15(7):1300-1311. doi: 10.1093/ckj/sfac018. eCollection 2022 Jul.
PubMed 3575673311. United States Renal Data System. 2024 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2024.
10. Registro Estatal Únicio de Enfermedad Renal Crónica del Estado de Aguascalientes. Instituto de Servicios de Salud del Estado de Aguascalientes. https://www.issea.gob.mx/ercpub/en/RepPrevalenciaErcPbiPubV2.asp Date: January 11, 2026
Garcia-Garcia G, Gutierrez-Padilla A, Perez-Gomez HR, Chavez-Iniguez JS, Morraz-Mejia EF, Amador-Jimenez MJ, Romero-Munoz AC, Gonzalez-De la Pena MDM, Klarenbach S, Tonelli M. Chronic kidney disease of unknown cause in Mexico: The case of Poncitlan, Jalisco. Clin Nephrol. 2020 Supplement-Jan;93(1):42-48. doi: 10.5414/CNP92S107.
PubMed 31397272Gutierrez-Pena M, Zuniga-Macias L, Marin-Garcia R, Ovalle-Robles I, Garcia-Diaz AL, Macias-Guzman MJ, Delgado-Bentites A, Macias-Diaz DM, Prado-Aguilar CA, Vega de la Rosa A, Delgadillo-Castaneda R, Chew-Won A, Reyes-Acevedo R, Reyes-Campos DM, Martinez-Guevara MA, Mendoza-Enciso EA, Nava-Becerra B, Piza-Jimenez MA, Arreola Guerra JM. High prevalence of end-stage renal disease of unknown origin in Aguascalientes Mexico: role of the registry of chronic kidney disease and renal biopsy in its approach and future directions. Clin Kidney J. 2021 Jan 15;14(4):1197-1206. doi: 10.1093/ckj/sfaa229. eCollection 2021 Apr.
PubMed 34094519Barquera S, Hernandez-Barrera L, Trejo-Valdivia B, Shamah T, Campos-Nonato I, Rivera-Dommarco J. [Obesity in Mexico, prevalence andtrends in adults. Ensanut 2018-19.]. Salud Publica Mex. 2020 Nov-Dec;62(6):682-692. doi: 10.21149/11630. Spanish.
PubMed 33620965Arreola Guerra JM, Martinez-Martinez JI. Multifactorial chronic kidney disease. Nephrol Dial Transplant. 2026 Jan 30;41(2):233-242. doi: 10.1093/ndt/gfaf122.
PubMed 40613565
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Persistent Albuminuria: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07405216
- Acronym / sponsor ID
- IECA-MEX / INAER2026-1
- Conditions
- Chronic Kidney Disease (Mild to Moderate), Albuminuria, Adolescent, Sodium Glucose Co-Transporter 2 Inhibitors
- Keywords
- Chronic kidney disease, Persistent albuminuria, sodium glucose co-transporter 2 inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centenario Hospital Miguel HidalgoUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 12 Feb 2026 (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.
Chronic kidney disease (CKD) is highly prevalent in the state of Aguascalientes, Mexico, particularly among adolescents and young adults. Epidemiologic and histologic studies suggest that this burden is largely driven by reduced nephron endowment of prenatal origin, leading to compensatory glomerular hyperfiltration, adaptive podocytopathy, and persistent albuminuria at early stages of disease.
Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have demonstrated nephroprotective effects in adult populations with CKD, including reductions in albuminuria and slowing of disease progression, independent of diabetes status. However, no randomized controlled trials have evaluated the efficacy and safety of SGLT2 inhibitors in adolescents with early-stage CKD and persistent albuminuria.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether treatment with an SGLT2 inhibitor reduces albuminuria in adolescents aged 14 to 18 years with persistent microalbuminuria (albumin-to-creatinine ratio 30-300 mg/g) and preserved kidney function. Participants will be randomized in a 2:1 ratio to receive dapagliflozin 10 mg daily or placebo for six months. The primary outcome is the change in urinary albumin-to-creatinine ratio from baseline to six months. Secondary outcomes include changes in estimated glomerular filtration rate and safety outcomes.
Detailed description
Chronic kidney disease (CKD) is a major global health problem and represents one of the fastest-growing causes of mortality worldwide. In the state of Aguascalientes, Mexico, CKD prevalence is among the highest reported globally, with an unusually high burden affecting adolescents and young adults.
Statewide screening programs and renal biopsy registries have identified a distinct epidemiologic and histologic pattern in this region. Adolescents with early-stage CKD frequently present with persistent albuminuria, glomerulomegaly, absence of interstitial fibrosis, and adaptive podocytopathy, findings consistent with reduced nephron endowment of prenatal origin. Over time, these lesions may progress to adaptive focal segmental glomerulosclerosis and clinically significant CKD in young adulthood. The predominant pathogenic mechanism in this population is believed to be glomerular hyperfiltration.
Pharmacologic therapies targeting hyperfiltration have proven efficacy in slowing CKD progression. Renin-angiotensin-aldosterone system inhibitors are standard of care, and more recently, sodium-glucose cotransporter-2 inhibitors have demonstrated substantial nephroprotective effects in adult populations, including patients without diabetes and across a wide range of albuminuria levels. Despite this evidence, adolescents and patients with early-stage CKD (G1-G2 A2) have been systematically excluded from major randomized trials.
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of an SGLT2 inhibitor in adolescents with persistent albuminuria and preserved kidney function. Eligible participants are adolescents aged 14 to 18 years residing in Aguascalientes with persistent microalbuminuria (albumin-to-creatinine ratio 30-300 mg/g), estimated glomerular filtration rate ≥60 mL/min/1.73 m², and no identifiable secondary cause of kidney disease.
After screening and baseline evaluation-including medical history, laboratory testing, immunologic studies, and renal ultrasound-eligible participants will be randomized in a 2:1 ratio to receive dapagliflozin 10 mg daily or matching placebo for a total duration of six months. All participants will receive standardized nutritional counseling.
Follow-up visits will occur every two months and will include clinical assessment, physical examination, blood pressure measurement, and laboratory testing. Urinary albumin-to-creatinine ratio will be measured using standardized laboratory methods.
The primary endpoint is the change in urinary albumin-to-creatinine ratio from baseline to six months, analyzed using log-transformed values. Secondary endpoints include changes in estimated glomerular filtration rate and assessment of safety outcomes, including adverse events such as hypotension and urinary tract infections.
This trial seeks to generate high-quality evidence on the efficacy and safety of SGLT2 inhibitors in adolescents with early-stage CKD, a population with a disproportionate disease burden and limited therapeutic evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin (10mg Tab)Adolescents with persistent albuminuria |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 10 mg daily |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Residence in Aguascalientes
- Persistent albuminuria (ACR >30 and <300 mg/g)
- Estimated glomerular filtration rate ≥60 mL/min/1.73 m²
- No identifiable secondary cause (e.g., lupus, diabetes mellitus)
- Renal biopsy showing adaptive podocytopathy or perihilar focal segmental glomerulosclerosis -
Key exclusion criteria (4 listed)
- Hypoalbuminemia
- Nephrotic syndrome
- Persistent macroalbuminuria (ACR >300 mg/g)
- Secondary causes of CKD, including congenital anomalies of the kidney and urinary tract or polycystic kidney disease -
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 (10mg Tab)Dapagliflozin 10 mg daily | Drug | Dapagliflozin |
| PlaceboPlacebo 10 mg daily | Drug | Placebo |
Primary outcome
Albuminuria
Time frame: 2, 4 and 6 months
The urinary albumin-to-creatinine ratio (ACR) will be calculated. The primary endpoint will be the log-transformed difference between baseline and six-month ACR. Absolute and relative (% reduction) changes in ACR will also be reported.
1 secondary outcome
Glomerular filtration rate
Time frame: 2,4 and 6 months
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 27 Apr 2026.
- Background: PubMed 40470996Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.
- Background: PubMed 38308513Kanbay M, Copur S, Bakir CN, Covic A, Ortiz A, Tuttle KR. Glomerular hyperfiltration as a therapeutic target for CKD. Nephrol Dial Transplant. 2024 Jul 31;39(8):1228-1238. doi: 10.1093/ndt/gfae027.
- Background: PubMed 41202026Staplin N, Roddick AJ, Neuen BL, Anker SD, Bhatt DL, Butler J, Cherney DZ, Docherty KF, Fletcher RA, Inzucchi SE, Jardine M, Mahaffey KW, McGuire DK, McMurray JJV, Neal B, Packer M, Patel SM, Perkovic V, Sabatine MS, Solomon S, Vaduganathan M, Wanner C, Wheeler DC, Zannad F, Haynes R, Heerspink HJL, Herrington WG; SGLT2 Inhibitor Meta-Analysis Cardio-Renal Trialists' Consortium (SMART-C). Effects of Sodium Glucose Cotransporter 2 Inhibitors by Diabetes Status and Level of Albuminuria: A Meta-Analysis. JAMA. 2026 Jan 20;335(3):220-232. doi: 10.1001/jama.2025.20835.
- Background: PubMed 32970396Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
- Background: PubMed 36331190The EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Mayne KJ, Ng SYA, Sammons E, Zhu D, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney D, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Petrini M, Massey D, Eilbracht J, Brueckmann M, Landray MJ, Baigent C, Haynes R. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan 12;388(2):117-127. doi: 10.1056/NEJMoa2204233. Epub 2022 Nov 4.
- Background: PubMed 38490803Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
- Background: PubMed 40536455Ortiz A, Arreola Guerra JM, Chan JCN, Jha V, Kramer H, Nicholas SB, Pavkov ME, Wanner C, Wong LP, Cheung M, King JM, Grams ME, Jadoul M, Tuttle KR; Conference Participants. Preventing chronic kidney disease and maintaining kidney health: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 2025 Oct;108(4):555-571. doi: 10.1016/j.kint.2025.04.005. Epub 2025 Jun 19.
- Background: PubMed 38280517Alcalde-Ortiz ML, Jaramillo-Arriaga F, Ibarra-Orenday D, Gonzalez-Dominguez SI, Calzada-Gallegos HD, Pinales-Jimenez AA, Carrillo-Aguilera IA, Flota-Marin DA, Collazo-Zamores MG, Aguirre-Moreno PD, Gutierrez-Hernandez SD, Del Toro-Delgado V, Delgadillo-Castaneda R, Sanchez-Ortiz MDR, Sanchez-Gonzalez I, Ramos-Medellin CL, Chew-Wong A, Macias-Diaz DM, Arreola-Guerra JM. Pediatric kidney dimensions and risk of persistent albuminuria in Mexican adolescents. Kidney Int. 2024 Apr;105(4):824-834. doi: 10.1016/j.kint.2023.11.034. Epub 2024 Jan 25.
- Background: PubMed 35756733Macias Diaz DM, Corrales Aguirre MDC, Reza Escalera AL, Tiscareno Gutierrez MT, Ovalle Robles I, Macias Guzman MJ, Garcia Diaz AL, Gutierrez Pena MC, Alvarado-Najera AN, Gonzalez Dominguez I, Villavicencio-Bautista JC, Herrera Rodriguez AA, Marin-Garcia R, Avelar Gonzalez FJ, Wong AC, Galvan Guerra E, Delgadillo Castaneda R, Prado Aguilar CA, Zuniga-Macias LP, Arreola Guerra JM. Histologic characterization and risk factors for persistent albuminuria in adolescents in a region of highly prevalent end-stage renal failure of unknown origin. Clin Kidney J. 2022 Jan 14;15(7):1300-1311. doi: 10.1093/ckj/sfac018. eCollection 2022 Jul.
- Background11. United States Renal Data System. 2024 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2024.
- Background10. Registro Estatal Únicio de Enfermedad Renal Crónica del Estado de Aguascalientes. Instituto de Servicios de Salud del Estado de Aguascalientes. https://www.issea.gob.mx/ercpub/en/RepPrevalenciaErcPbiPubV2.asp Date: January 11, 2026
- Background: PubMed 31397272Garcia-Garcia G, Gutierrez-Padilla A, Perez-Gomez HR, Chavez-Iniguez JS, Morraz-Mejia EF, Amador-Jimenez MJ, Romero-Munoz AC, Gonzalez-De la Pena MDM, Klarenbach S, Tonelli M. Chronic kidney disease of unknown cause in Mexico: The case of Poncitlan, Jalisco. Clin Nephrol. 2020 Supplement-Jan;93(1):42-48. doi: 10.5414/CNP92S107.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin (10mg Tab) in people with Chronic Kidney Disease (Mild to Moderate) and Albuminuria, run by Centenario Hospital Miguel Hidalgo 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 5 inclusion and 4 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 27 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jose Manuel Arreola Guerra, PhD, MD (+524494632049, dr.jmag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Albuminuria (time frame: 2, 4 and 6 months). 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 NCT07405216, which also lists 19 linked publications.
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 27 Apr 2026.