Renoprotective Effects of Dapagliflozin Versus Pentoxiphylline in Chronic Kidney Disease Patients

NCT06421870 | Recruiting Phase 3

• 1 other identifier: MD277/2023
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Kidneys have a vital role in glucose homeostasis by various mechanisms, one of the major mechanisms is through SGLT2. This role was commonly overlooked till development of the new SGLT2 inhibitors. (Ni, L., et al 2020) The SGLT2 inhibitor class of glucose-lowering agents has recently shown beneficial effects to reduce the onset and progression of renal complications in people with and without diabetes, through slow the decline in glomerular filtration rate (GFR), delaying the onset of microalbuminuria and slow or reverse the progression of proteinuria. (Nespoux, J., \& Vallon, V. 2020) The drug pentoxifylline is a methyl-xanthine derivative and a nonselective phosphodiesterase inhibitor with anti-inflammatory, antiproliferative and antifibrotic actions currently indicated for peripheral artery disease. (Panchapakesan U et al.,2018) Chronic kidney disease is a progressive disorder in which patients are treated according to complications presented such as hypocalcemia, hyperkalemia, anemia and metabolic acidosis.

Conditions

Chronic Kidney Diseases

Keywords

Dapagliflozin; Chronic kidney disease; Pentoxiphylline

Outcome Measures

Primary Outcomes (2)

• Change in estimated glomerular filtration rate

  eGFR will be based on serum creatinine and will be calculated by CKD-EPI 2021

  1 year

• Change in proteinuria

  Proteinuria quantification done by urine protein to creatinine ratio

  1 year

Study Arms (3)

Dapagliflozin arm

ACTIVE COMPARATOR

70 patients will take dapagliflozin 10 mg per day for 1 year in addition to standard management for chronic kidney disease

Drug: Dapagliflozin 10mg Tab

Pentoxiphylline arm

ACTIVE COMPARATOR

70 patients will take pentoxifylline 400 mg twice daily for 1 year in addition to standard management for chronic kidney disease

Drug: Pentoxifylline 400 MG

Control

NO INTERVENTION

70 patients won't take either dapagliflozin or pentoxiphylline but they will continue their standard management for chronic kidney disease

Interventions

Dapagliflozin 10mg Tab DRUG

Patients will be given dapagliflozin 10 mg once daily

Dapagliflozin arm

Pentoxifylline 400 MG DRUG

Patients will be given pentoxyifylline 400 mg twice daily

Pentoxiphylline arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• CKD stage 2 and 3

You may not qualify if:

• Diabetes mellitus
• History of recurrent or recent genitourinary infections
• Immunosuppressive medications
• Malignancy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 1181, Egypt

RECRUITING

Related Publications (5)

• Ni L, Yuan C, Chen G, Zhang C, Wu X. SGLT2i: beyond the glucose-lowering effect. Cardiovasc Diabetol. 2020 Jun 26;19(1):98. doi: 10.1186/s12933-020-01071-y.

  PMID: 32590982 BACKGROUND

• Nespoux J, Vallon V. Renal effects of SGLT2 inhibitors: an update. Curr Opin Nephrol Hypertens. 2020 Mar;29(2):190-198. doi: 10.1097/MNH.0000000000000584.

  PMID: 31815757 BACKGROUND

• Panchapakesan U, Pollock C. Drug repurposing in kidney disease. Kidney Int. 2018 Jul;94(1):40-48. doi: 10.1016/j.kint.2017.12.026. Epub 2018 Apr 6.

  PMID: 29628139 BACKGROUND

• Cersosimo E, Solis-Herrera C, Triplitt C. Inhibition of renal glucose reabsorption as a novel treatment for diabetes patients. J Bras Nefrol. 2014 Jan-Mar;36(1):80-92. doi: 10.5935/0101-2800.20140014.

  PMID: 24676619 BACKGROUND

• DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab. 2012 Jan;14(1):5-14. doi: 10.1111/j.1463-1326.2011.01511.x.

  PMID: 21955459 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin; Pentoxifylline

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

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Saeed A Saeed, Professor

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Mohamed A Mohamed, MSc

CONTACT

1119090018; Mohammed.Ashraf@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

EG (1)