Chronic Kidney Disease Stage 5Phase 3NCT06982079
Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease
A Phase 3 study testing Dapagliflozin 10 mg in people with Chronic Kidney Disease Stage 5 and CKD Stage 4, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 5, CKD Stage 4
- What is being tested?
- Dapagliflozin 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Nov 2026
- Phase
- Phase 3
- 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
- Adult patients aged eighteen or older.
- Patients with advanced chronic kidney disease (i.e., eGFR < 20 mL/min/1.73m2)not on dialysis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo
Mohamed Ahmed, MSc, +201002831275, mohamed.mohyeldin@med.asu.edu.eg
About this study
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:
- Does dapagliflozin reduce the rate of decline in kidney function or progression to end-stage kidney disease in adults with advanced CKD?
- Does dapagliflozin reduce the risk of death from cardiovascular or renal causes in patients with advanced CKD?
Researchers will compare dapagliflozin to a placebo to see if dapagliflozin improves kidney and cardiovascular outcomes in this high-risk population.
Read the detailed description
Sodium-glucose cotransporter 2 (SGLT2) inhibitors, originally developed as oral antihyperglycemic agents for managing type 2 diabetes, have quickly gained recognition for their broad therapeutic benefits beyond glycemic control. Since their clinical introduction in 2012, SGLT2 inhibitors have demonstrated significant renoprotective and cardioprotective effects, reshaping treatment approaches in nephrology and cardiology.
Although these drugs have shown great promise, major clinical trials have typically excluded patients with advanced chronic kidney disease (CKD) (eGFR < 20 mL/min/1.73m²), those already on dialysis, and kidney transplant recipients-populations at the highest risk of kidney failure, cardiovascular complications, and mortality. This exclusion has left a critical gap in understanding the full potential of SGLT2 inhibitors in the most vulnerable patients. As such, current KDIGO guidelines have not recommended initiating SGLT2 inhibitors in patients with eGFR < 20 mL/min/1.73m².
CKD is a global health crisis, affecting approximately 10% of adults worldwide, with prevalence rising in Egypt, where 13% of adults are affected, especially in underserved rural areas. By 2040, CKD is projected to become the fifth leading cause of death worldwide.
For patients with kidney failure, the primary treatment options are renal replacement therapies like dialysis or transplantation. However, due to the scarcity of donor kidneys and the frequent presence of comorbidities in older populations, transplantation is often unfeasible. Consequently, most end-stage kidney disease (ESKD) patients rely on dialysis, a therapy that significantly lowers quality of life and increases mortality risk.
Preserving kidney function is a critical goal in CKD management, which is closely linked to better patient outcome. Incremental dialysis, a strategy aimed at preserving residual kidney function (RKF), shows promise but lacks robust clinical validation. Increasing evidence suggests that SGLT2 inhibitors, even in patients with advanced CKD, may offer significant reno- and cardioprotective benefits, reinforcing the need for further research into their efficacy in this population.
For instance, in the DAPA-CKD trial, which included patients with an eGFR as low as 25 mL/min/1.73m², dapagliflozin demonstrated a consistent reduction in cardiovascular and renal outcomes, even in those with severely impaired kidney function. A subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR <30 mL/min/1.73m2 to the remainder of the trial population with better kidney function, demonstrated that the efficacy of dapagliflozin in reducing cardiovascular and renal outcomes persisted in the population with impaired kidney function. Remarkably, patients who initiated dialysis during the trial continued to receive dapagliflozin or placebo, and those treated with dapagliflozin experienced a 21% reduction in relative risk for mortality. These findings challenge the traditional boundaries of SGLT2 inhibitor use, indicating potential benefits even in populations previously excluded from major trials.
Recent findings from the DAPA advKD trial (NCT05196347) further support this potential: in 180 patients with CKD stages 4-5 (eGFR 10-30 mL/min/1.73m²), dapagliflozin significantly slowed eGFR decline (-2.24 vs. -3.67 mL/min/1.73m²/yr in controls, p=0.019) and reduced composite renal outcomes (HR 0.50, p=0.019) over 1.6 years, despite a higher incidence of transient eGFR dips in the treatment group.
The 2023 UK Kidney Association Clinical Practice Guideline reinforces this paradigm shift, issuing a Grade 2B recommendation to consider SGLT2 inhibitor initiation in patients with eGFR <20 mL/min/1.73m² to slow disease progression. This guidance is supported by indirect evidence from trials continuing SGLT2 inhibition until kidney replacement therapy initiation, as well as EMPA-KIDNEY data showing unattenuated renal benefits down to eGFR 15 mL/min/1.73m².
Emerging clinical data further supports the efficacy of SGLT2 inhibitors in preserving RKF in patients undergoing dialysis. Recent case series have shown promising results, such as significant improvements in residual kidney urea clearance and reduced proteinuria among patients undergoing incremental hemodialysis while receiving SGLT2 inhibitors. Similarly, in patients on peritoneal dialysis, SGLT2 inhibitors have been effective in preserving RKF. Pharmacokinetic data also suggest that dapagliflozin is well tolerated, minimally dialyzable, and exhibits non-accumulating pharmacokinetic properties in patients on dialysis.
Given the substantial benefits of SGLT2 inhibitors in patients with less severe CKD, coupled with preliminary evidence suggesting their potential in advanced CKD and dialysis populations, there is a pressing need to explore their long-term efficacy and safety in these high-risk groups. This research aims to fill that gap, with the potential to redefine CKD management and offer new hope to patients facing the highest risks of poor outcomes.
- Conditions
- Chronic Kidney Disease Stage 5, CKD Stage 4
- Being tested
- Dapagliflozin 10 mg
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 mgDrug
Dapagliflozin 10 mg will be added in addition to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Eligible patients will receive dapagliflozin 10 mg in addition to standard of care Receives: Drug: Dapagliflozin 10 mg |
| Control arm | No intervention | Eligible patients will receive standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the eGFR slope
To determine whether dapagliflozin is superior to standard of care only in reducing the eGFR slope.
Measured: 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
Measured: 1 year
Secondary outcomes (2)
Incidence of hospitalization for heart failure
To determine if dapagliflozin is superior to standard of care only in reducing the incidence of heart failure
Measured: 1 year
Number of participants with all-cause mortality
To determine whether dapagliflozin is superior to standard of care only in reducing all-cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 May 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 5Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982079
- Sponsor's protocol ID
- FMASU MD102/2025
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38490803Roddick 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.
PubMed 37880609Moral 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.
PubMed 39202480Levey 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.
PubMed 31473020Kalantar-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.
PubMed 34175022Inker 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.
PubMed 34554658Heerspink 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 32970396Heerspink 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.
PubMed 33792669Foreman 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.
PubMed 30340847Dobre 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.
PubMed 35618341De 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.
PubMed 37509547Chertow 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.
PubMed 34272327Barreto 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.
PubMed 37227937
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06982079
- Acronym / sponsor ID
- FMASU MD102/2025
- Conditions
- Chronic Kidney Disease Stage 5, CKD Stage 4
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 May 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.
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:
- Does dapagliflozin reduce the rate of decline in kidney function or progression to end-stage kidney disease in adults with advanced CKD?
- Does dapagliflozin reduce the risk of death from cardiovascular or renal causes in patients with advanced CKD?
Researchers will compare dapagliflozin to a placebo to see if dapagliflozin improves kidney and cardiovascular outcomes in this high-risk population.
Detailed description
Sodium-glucose cotransporter 2 (SGLT2) inhibitors, originally developed as oral antihyperglycemic agents for managing type 2 diabetes, have quickly gained recognition for their broad therapeutic benefits beyond glycemic control. Since their clinical introduction in 2012, SGLT2 inhibitors have demonstrated significant renoprotective and cardioprotective effects, reshaping treatment approaches in nephrology and cardiology.
Although these drugs have shown great promise, major clinical trials have typically excluded patients with advanced chronic kidney disease (CKD) (eGFR < 20 mL/min/1.73m²), those already on dialysis, and kidney transplant recipients-populations at the highest risk of kidney failure, cardiovascular complications, and mortality. This exclusion has left a critical gap in understanding the full potential of SGLT2 inhibitors in the most vulnerable patients. As such, current KDIGO guidelines have not recommended initiating SGLT2 inhibitors in patients with eGFR < 20 mL/min/1.73m².
CKD is a global health crisis, affecting approximately 10% of adults worldwide, with prevalence rising in Egypt, where 13% of adults are affected, especially in underserved rural areas. By 2040, CKD is projected to become the fifth leading cause of death worldwide.
For patients with kidney failure, the primary treatment options are renal replacement therapies like dialysis or transplantation. However, due to the scarcity of donor kidneys and the frequent presence of comorbidities in older populations, transplantation is often unfeasible. Consequently, most end-stage kidney disease (ESKD) patients rely on dialysis, a therapy that significantly lowers quality of life and increases mortality risk.
Preserving kidney function is a critical goal in CKD management, which is closely linked to better patient outcome. Incremental dialysis, a strategy aimed at preserving residual kidney function (RKF), shows promise but lacks robust clinical validation. Increasing evidence suggests that SGLT2 inhibitors, even in patients with advanced CKD, may offer significant reno- and cardioprotective benefits, reinforcing the need for further research into their efficacy in this population.
For instance, in the DAPA-CKD trial, which included patients with an eGFR as low as 25 mL/min/1.73m², dapagliflozin demonstrated a consistent reduction in cardiovascular and renal outcomes, even in those with severely impaired kidney function. A subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR <30 mL/min/1.73m2 to the remainder of the trial population with better kidney function, demonstrated that the efficacy of dapagliflozin in reducing cardiovascular and renal outcomes persisted in the population with impaired kidney function. Remarkably, patients who initiated dialysis during the trial continued to receive dapagliflozin or placebo, and those treated with dapagliflozin experienced a 21% reduction in relative risk for mortality. These findings challenge the traditional boundaries of SGLT2 inhibitor use, indicating potential benefits even in populations previously excluded from major trials.
Recent findings from the DAPA advKD trial (NCT05196347) further support this potential: in 180 patients with CKD stages 4-5 (eGFR 10-30 mL/min/1.73m²), dapagliflozin significantly slowed eGFR decline (-2.24 vs. -3.67 mL/min/1.73m²/yr in controls, p=0.019) and reduced composite renal outcomes (HR 0.50, p=0.019) over 1.6 years, despite a higher incidence of transient eGFR dips in the treatment group.
The 2023 UK Kidney Association Clinical Practice Guideline reinforces this paradigm shift, issuing a Grade 2B recommendation to consider SGLT2 inhibitor initiation in patients with eGFR <20 mL/min/1.73m² to slow disease progression. This guidance is supported by indirect evidence from trials continuing SGLT2 inhibition until kidney replacement therapy initiation, as well as EMPA-KIDNEY data showing unattenuated renal benefits down to eGFR 15 mL/min/1.73m².
Emerging clinical data further supports the efficacy of SGLT2 inhibitors in preserving RKF in patients undergoing dialysis. Recent case series have shown promising results, such as significant improvements in residual kidney urea clearance and reduced proteinuria among patients undergoing incremental hemodialysis while receiving SGLT2 inhibitors. Similarly, in patients on peritoneal dialysis, SGLT2 inhibitors have been effective in preserving RKF. Pharmacokinetic data also suggest that dapagliflozin is well tolerated, minimally dialyzable, and exhibits non-accumulating pharmacokinetic properties in patients on dialysis.
Given the substantial benefits of SGLT2 inhibitors in patients with less severe CKD, coupled with preliminary evidence suggesting their potential in advanced CKD and dialysis populations, there is a pressing need to explore their long-term efficacy and safety in these high-risk groups. This research aims to fill that gap, with the potential to redefine CKD management and offer new hope to patients facing the highest risks of poor outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10 mgEligible patients will receive dapagliflozin 10 mg in addition to standard of care |
| Control arm | No intervention | –Eligible patients will receive standard of care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged eighteen or older.
- Patients with advanced chronic kidney disease (i.e., eGFR < 20 mL/min/1.73m2)not on dialysis
Key exclusion criteria (7 listed)
- 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.
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 mgDapagliflozin 10 mg will be added in addition to standard of care | Drug | Dapagliflozin |
Primary outcome
Change in the eGFR slope
Time frame: 1 year
To determine whether dapagliflozin is superior to standard of care only in reducing the eGFR slope.
Time to start of renal replacement therapy
Time frame: 1 year
Kidney failure is defined as need for renal replacement therapy either by hemodialysis or kidney transplant
2 secondary outcomes
Incidence of hospitalization for heart failure
Time frame: 1 year
Number of participants with all-cause mortality
Time frame: 1 year
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 21 May 2025.
- 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 37880609Roddick 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.
- Background: PubMed 39202480Moral 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.
- Background: PubMed 31473020Levey 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.
- Background: PubMed 34175022Kalantar-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.
- Background: PubMed 34554658Inker 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.
- 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 33792669Heerspink 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.
- Background: PubMed 30340847Foreman 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.
- Background: PubMed 35618341Dobre 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10 mg in people with Chronic Kidney Disease Stage 5 and CKD Stage 4, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 7 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 21 May 2025. 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 Egypt. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the eGFR slope (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06982079, which also lists 13 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 21 May 2025.