AzTrials
AzTrials

Kidney DiseasesPhase 3NCT06759077

Cardio Protective Effect of SGL2I in Hemodialysis Patients and Its Impact on Patient Quality of Life

A Phase 3 study testing Dapagliflozin (DAPA) in people with Kidney Diseases, run by Al-Azhar University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

If this study has a cardio protective effect it will affect the mortality and morbidity of advanced CKD patients and improve their quality of life Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Diseases
What is being tested?
Dapagliflozin (DAPA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteEgypt
Study dates
1 Feb 2025to 28 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Patients with CKD stage5 (i.e., eGFR < 15 mL/min/1.73m2) (Inker et al., 2021)

Who cannot join

  • patients who refuse to sign consent
  • Patients with acute heart failure , will exclude patients with known prior ischemic heart diseases or ischemic cardiomyopathy
  • Autosomal dominant polycystic kidney disease (ADPKD).
  • Type 1 diabetes mellitus
  • History of ketoacidosis in the last year.
  • Known hypersensitivity to SGLT2 inhibitors.
  • Known severe hepatic impairment (Child-Pugh class C)
  • Pregnant or breastfeeding females

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • faculty of pharmacy (girls )ALAzhar university

    Cairo

Other trials in Egypt

About this study

Official title: Potential Beneficial Cardio Protective Effect of SGL2I in Hemodialysis Patients and Its Impact on Patient Quality of Life

If this study has a cardio protective effect it will affect the mortality and morbidity of advanced CKD patients and improve their quality of life

Read the detailed description

Cardiovascular disease is the leading cause of mortality, accounting for >50% of deaths with known causes, while cardiovascular mortality is 9-fold higher in these patients compared with age- and sex-matched individuals in the general population Particularly, heart failure poses a significant challenge in the management of ESKD. It frequently develops after initiation of dialysis and is a prominent mortality risk factor among these patients When CKD patients develop HF, increased sodium and fluid retention, and vascular tension will lead to increased preload of the heart. The increased ventricular wall pressure will lead to release biomarkers like natriuretic peptides (NP). Therefore, biomarkers of myocardial stretch are commonly used in the diagnosis and prognosis evaluation of HF. It is worth noting that the negative predictive value of NP is extremely high (0.94-0.98), while the positive predictive value is slightly lower, (0.44-0.57) for chronic heart failure (CHF) and (0.66-0.67) for acute heart failure (AHF), Commonly used myocardial stretch marker include NT-pro BNP .

NT-pro BNP has the advantage that Accuracy of negative diagnosis is extremely high; The prognostic value is the most powerful, especially in CKD stages 4-5 and dialysis patients Traditional therapies to prevent CVD complications in the general population have shown to be ineffective in Chronic kidney disease (CKD). To address the unmet need, further research is needed to evaluate novel therapeutic strategies to improve cardiovascular outcomes among patients on dialysis .

Over the last several years, Sodium-glucose transporter type 2 (SGLT2) inhibitors have been shown to confer substantial kidney and cardiovascular benefits among patients with type 2 diabetes, heart failure, and/or high-risk CKD .

Secondary analyses from these landmark trials demonstrated consistent benefits of SGLT2 inhibitors across many subgroups, supporting the widespread use and incorporation in clinical practice guidelines of this new kidney and cardio protective drug class.

Conditions
Kidney Diseases
Being tested
Dapagliflozin (DAPA)
Medical subject headings
Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapagliflozin (DAPA)Drug

    adult patients with advanced CKD who will take SGL2I(DAPAGLIFLOZINE at a dose (10 mg/day) orally for 6months

Study groups in NCT06759077
Study groupRoleWhat they receive
standard treatmentNo interventionAdult patients with advanced CKD who will take the standard treatment for 6months.
interventional GroupExperimentaladult patients with advanced CKD who will take SGL2I(DAPAGLIFLOZINE at a dose (10 mg/day) orally for 6months
Receives: Drug: Dapagliflozin (DAPA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigate the cardio protective effect of SGL2 inhibitors(DAPAGLIFLOZINE (10 mg/day)) in dialysis patients ,by measuring human N terminal pro brain natriuretic peptide (N -pro BNB) at baseline and after 6months

    Measured: up to 24 weeks

Secondary outcomes (1)

  1. Assess the degree of quality of life by Heart Failure Patient Questionnaire to assess cardiac support in dialysis patients

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start1 Feb 2025
  3. Primary completion28 Mar 2026
  4. Study completion28 Apr 2026

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06759077
Sponsor's protocol ID
FWA 000017585
Status last verified
Sep 2026
First submitted
30 Dec 2024
Last updated
1 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kobo O, Abramov D, Davies S, Ahmed SB, Sun LY, Mieres JH, Parwani P, Siudak Z, Van Spall HGC, Mamas MA. CKD-Associated Cardiovascular Mortality in the United States: Temporal Trends From 1999 to 2020. Kidney Med. 2022 Dec 28;5(3):100597. doi: 10.1016/j.xkme.2022.100597. eCollection 2023 Mar.

    PubMed 36814454

  • Rashid AM, Jamil A, Khan Z, Shakoor M, Kamal UH, Khan II, Akram A, Shahabi M, Yamani N, Ali S, Fatima K, Kamdi A, Junaid M, Khan AM, Mattumpuram J, Perswani P. Trends in mortality related to kidney failure and diabetes mellitus in the United States: a 1999-2020 analysis. J Nephrol. 2024 Sep;37(7):1833-1841. doi: 10.1007/s40620-024-01990-z. Epub 2024 Jun 25.

    PubMed 38916852

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

    PubMed 34447992

  • Han X, Zhang S, Chen Z, Adhikari BK, Zhang Y, Zhang J, Sun J, Wang Y. Cardiac biomarkers of heart failure in chronic kidney disease. Clin Chim Acta. 2020 Nov;510:298-310. doi: 10.1016/j.cca.2020.07.040. Epub 2020 Jul 23.

    PubMed 32710942

  • Siddiqui R, Obi Y, Dossabhoy NR, Shafi T. Is There a Role for SGLT2 Inhibitors in Patients with End-Stage Kidney Disease? Curr Hypertens Rep. 2024 Dec;26(12):463-474. doi: 10.1007/s11906-024-01314-3. Epub 2024 Jun 24.

    PubMed 38913113

  • McGuire DK, Shih WJ, Cosentino F, Charbonnel B, Cherney DZI, Dagogo-Jack S, Pratley R, Greenberg M, Wang S, Huyck S, Gantz I, Terra SG, Masiukiewicz U, Cannon CP. Association of SGLT2 Inhibitors With Cardiovascular and Kidney Outcomes in Patients With Type 2 Diabetes: A Meta-analysis. JAMA Cardiol. 2021 Feb 1;6(2):148-158. doi: 10.1001/jamacardio.2020.4511.

    PubMed 33031522

  • Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int. 2022 Nov;102(5S):S1-S127. doi: 10.1016/j.kint.2022.06.008. No abstract available.

    PubMed 36272764

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin (DAPA) in people with Kidney Diseases, run by Al-Azhar 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 1 Oct 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigate the cardio protective effect of SGL2 inhibitors(DAPAGLIFLOZINE (10 mg/day)) in dialysis patients ,by measuring human N terminal pro brain natriuretic peptide (N -pro BNB) at baseline and after 6months (time frame: up to 24 weeks). 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 NCT06759077, which also lists 7 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 1 Oct 2026.

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