Renoprotective Effects of Dapagliflozin Versus Pentoxiphylline in Chronic Kidney Disease Patients

Sponsor
Ain Shams University
Study ID
NCT06421870
Phase
PHASE3
Status
Unknown

Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Patients will be given dapagliflozin 10 mg once daily
  • Pentoxifylline 400 MG — DRUG
    Patients will be given pentoxyifylline 400 mg twice daily

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
May 2024
Primary completion
May 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin arm
    70 patients will take dapagliflozin 10 mg per day for 1 year in addition to standard management for chronic kidney disease
  • Active Comparator: Pentoxiphylline arm
    70 patients will take pentoxifylline 400 mg twice daily for 1 year in addition to standard management for chronic kidney disease
  • No Intervention: Control
    70 patients won't take either dapagliflozin or pentoxiphylline but they will continue their standard management for chronic kidney disease

Primary Outcome Measure

Change in estimated glomerular filtration rate [ Time Frame: 1 year ]

Central Contacts

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