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

NCT06759077 | Active Not Recruiting Phase 3

• 1 other identifier: FWA 000017585
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (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

  up to 24 weeks

Secondary Outcomes (1)

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

  up to 24 weeks

Study Arms (2)

standard treatment

NO INTERVENTION

Adult patients with advanced CKD who will take the standard treatment for 6months.

interventional Group

EXPERIMENTAL

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

Drug: Dapagliflozin (DAPA)

Interventions

Dapagliflozin (DAPA) DRUG

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

interventional Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

faculty of pharmacy (girls )ALAzhar university

Cairo, Egypt

Location

Related Publications (7)

• 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.

  PMID: 36814454 BACKGROUND

• 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.

  PMID: 38916852 BACKGROUND

• 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.

  PMID: 34447992 BACKGROUND

• 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.

  PMID: 32710942 BACKGROUND

• 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.

  PMID: 38913113 BACKGROUND

• 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.

  PMID: 33031522 BACKGROUND

• 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.

  PMID: 36272764 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist at Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University Master Degree of Pharmaceutical Sciences (Clinical Pharmacy), Al-Azhar University (2023)

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: December 28, 2024
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

EG (1)