Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease

NCT06982079 | Recruiting Phase 3

• 1 other identifier: FMASU MD102/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether dapagliflozin can reduce the risk of worsening kidney function or death from cardiovascular or renal causes in adults with advanced chronic kidney disease (CKD), with or without type 2 diabetes. The main questions it aims to answer are:

1. 1.Does dapagliflozin reduce the rate of decline in kidney function or progression to end-stage kidney disease in adults with advanced CKD?
2. 2.Does dapagliflozin reduce the risk of death from cardiovascular or renal causes in patients with advanced CKD?

Conditions

Chronic Kidney Disease Stage 5; CKD Stage 4

Outcome Measures

Primary Outcomes (2)

• Change in the eGFR slope

  To determine whether dapagliflozin is superior to standard of care only in reducing the eGFR slope.

  1 year

• Time to start of renal replacement therapy

  Kidney failure is defined as need for renal replacement therapy either by hemodialysis or kidney transplant

  1 year

Secondary Outcomes (2)

• Incidence of hospitalization for heart failure

  1 year

• Number of participants with all-cause mortality

  1 year

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Eligible patients will receive dapagliflozin 10 mg in addition to standard of care

Drug: Dapagliflozin 10 mg

Control arm

NO INTERVENTION

Eligible patients will receive standard of care only

Interventions

Dapagliflozin 10 mg DRUG

Dapagliflozin 10 mg will be added in addition to standard of care

Dapagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged eighteen or older.
• Patients with advanced chronic kidney disease (i.e., eGFR \< 20 mL/min/1.73m2)not on dialysis

You may not qualify if:

• Autosomal dominant polycystic kidney disease (ADPKD).
• Type 1 diabetes mellitus
• Patients on SGLT2 inhibitors.
• History of ketoacidosis in the last 3 months.
• Known hypersensitivity to SGLT2 inhibitors.
• Known hepatic impairment.
• Pregnant or breastfeeding females.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

RECRUITING

Related Publications (13)

• Kidney 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.

  PMID: 38490803 BACKGROUND

• Roddick AJ, Wonnacott A, Webb D, Watt A, Watson MA, Staplin N, Riding A, Lioudaki E, Kuverji A, Kossi ME, Holmes P, Holloway M, Fraser D, Carvalho C, Burton JO, Bhandari S, Herrington WG, Frankel AH. UK Kidney Association Clinical Practice Guideline: Sodium-Glucose Co-transporter-2 (SGLT-2) Inhibition in Adults with Kidney Disease 2023 UPDATE. BMC Nephrol. 2023 Oct 25;24(1):310. doi: 10.1186/s12882-023-03339-3.

  PMID: 37880609 BACKGROUND

• Moral Berrio E, De La Flor JC, Arambarri Segura M, Rodriguez-Doyaguez P, Martinez Calero A, Zamora R, Cieza-Terrones M, Yuste-Lozano C, Sanchez de la Nieta Garcia MD, Nieto Iglesias J, Vozmediano Poyatos C. Effects of Sodium-Glucose Cotransporter 2 Inhibitors in Diabetic and Non-Diabetic Patients with Advanced Chronic Kidney Disease in Peritoneal Dialysis on Residual Kidney Function: In Real-World Data. Medicina (Kaunas). 2024 Jul 24;60(8):1198. doi: 10.3390/medicina60081198.

  PMID: 39202480 BACKGROUND

• Levey AS, Gansevoort RT, Coresh J, Inker LA, Heerspink HL, Grams ME, Greene T, Tighiouart H, Matsushita K, Ballew SH, Sang Y, Vonesh E, Ying J, Manley T, de Zeeuw D, Eckardt KU, Levin A, Perkovic V, Zhang L, Willis K. Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of CKD: A Scientific Workshop Sponsored by the National Kidney Foundation in Collaboration With the US Food and Drug Administration and European Medicines Agency. Am J Kidney Dis. 2020 Jan;75(1):84-104. doi: 10.1053/j.ajkd.2019.06.009. Epub 2019 Aug 28.

  PMID: 31473020 BACKGROUND

• Kalantar-Zadeh K, Jafar TH, Nitsch D, Neuen BL, Perkovic V. Chronic kidney disease. Lancet. 2021 Aug 28;398(10302):786-802. doi: 10.1016/S0140-6736(21)00519-5. Epub 2021 Jun 24.

  PMID: 34175022 BACKGROUND

• Inker LA, Eneanya ND, Coresh J, Tighiouart H, Wang D, Sang Y, Crews DC, Doria A, Estrella MM, Froissart M, Grams ME, Greene T, Grubb A, Gudnason V, Gutierrez OM, Kalil R, Karger AB, Mauer M, Navis G, Nelson RG, Poggio ED, Rodby R, Rossing P, Rule AD, Selvin E, Seegmiller JC, Shlipak MG, Torres VE, Yang W, Ballew SH, Couture SJ, Powe NR, Levey AS; Chronic Kidney Disease Epidemiology Collaboration. New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race. N Engl J Med. 2021 Nov 4;385(19):1737-1749. doi: 10.1056/NEJMoa2102953. Epub 2021 Sep 23.

  PMID: 34554658 BACKGROUND

• Heerspink 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.

  PMID: 32970396 BACKGROUND

• Heerspink HJL, Sjostrom CD, Jongs N, Chertow GM, Kosiborod M, Hou FF, McMurray JJV, Rossing P, Correa-Rotter R, Kurlyandskaya R, Stefansson BV, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Effects of dapagliflozin on mortality in patients with chronic kidney disease: a pre-specified analysis from the DAPA-CKD randomized controlled trial. Eur Heart J. 2021 Mar 31;42(13):1216-1227. doi: 10.1093/eurheartj/ehab094.

  PMID: 33792669 BACKGROUND

• Foreman KJ, Marquez N, Dolgert A, Fukutaki K, Fullman N, McGaughey M, Pletcher MA, Smith AE, Tang K, Yuan CW, Brown JC, Friedman J, He J, Heuton KR, Holmberg M, Patel DJ, Reidy P, Carter A, Cercy K, Chapin A, Douwes-Schultz D, Frank T, Goettsch F, Liu PY, Nandakumar V, Reitsma MB, Reuter V, Sadat N, Sorensen RJD, Srinivasan V, Updike RL, York H, Lopez AD, Lozano R, Lim SS, Mokdad AH, Vollset SE, Murray CJL. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. Lancet. 2018 Nov 10;392(10159):2052-2090. doi: 10.1016/S0140-6736(18)31694-5. Epub 2018 Oct 16.

  PMID: 30340847 BACKGROUND

• Dobre M. Safety of SGLT2 Inhibitors in CKD: Walking the Fine Line. Clin J Am Soc Nephrol. 2022 Jun;17(6):774-776. doi: 10.2215/CJN.04900422. Epub 2022 May 26. No abstract available.

  PMID: 35618341 BACKGROUND

• De La Flor JC, Villa D, Cruzado L, Apaza J, Valga F, Zamora R, Marschall A, Cieza M, Deira J, Rodeles M. Efficacy and Safety of the Use of SGLT2 Inhibitors in Patients on Incremental Hemodialysis: Maximizing Residual Renal Function, Is There a Role for SGLT2 Inhibitors? Biomedicines. 2023 Jul 6;11(7):1908. doi: 10.3390/biomedicines11071908.

  PMID: 37509547 BACKGROUND

• Chertow GM, Vart P, Jongs N, Toto RD, Gorriz JL, Hou FF, McMurray JJV, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Langkilde AM, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effects of Dapagliflozin in Stage 4 Chronic Kidney Disease. J Am Soc Nephrol. 2021 Sep;32(9):2352-2361. doi: 10.1681/ASN.2021020167. Epub 2021 Jul 16.

  PMID: 34272327 BACKGROUND

• Barreto J, Borges C, Rodrigues TB, Jesus DC, Campos-Staffico AM, Nadruz W, Luiz da Costa J, Bueno de Oliveira R, Sposito AC. Pharmacokinetic Properties of Dapagliflozin in Hemodialysis and Peritoneal Dialysis Patients. Clin J Am Soc Nephrol. 2023 Aug 1;18(8):1051-1058. doi: 10.2215/CJN.0000000000000196. Epub 2023 May 25.

  PMID: 37227937 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 21, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

EG (1)