Effect of Dapagliflozin in Non-Diabetic Patients With Nephrotic Syndrome.

Sponsor
Ain Shams University
Study ID
NCT05966818
Phase
PHASE4
Status
Unknown

Conditions

  • Nephrotic Syndrome

Eligibility Criteria

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

Interventions

  • Dapagliflozin and Standard therapy (ACEI or ARB). — DRUG
    Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).
  • Standard Therapy (ACEI or ARB). — DRUG
    Standard Therapy which include either ACEI or ARB for 24 weeks.

Study Details

Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intraglomerular hypertension, it was hypothesized that dapagliflozin acutely decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss such as nephrotic patients via a glucose independent hemodynamic mechanism. The aim of the study is to assess the effect of Dapagliflozin on proteinuria and estimated glomerular filtration rate in non-diabetic patients with nephrotic syndrome in order to slow the decline in kidney function and the progression to ESRD and to prevent the complications of nephrotic syndrome like thrombotic diseases, peritonitis, hyperuricemia, and recurrent infections.

Key Dates

Start date
Aug 1, 2023
Status verified
Jul 2023
Primary completion
Jan 1, 2024
Completion
Mar 1, 2024

Study Design

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

Arms

  • Active Comparator: Dapagliflozin group and Standard therapy which include either ACEI or ARB
    \- The first group (45 patients) will receive Dapagliflozin (Diglifloz) 10 mg orally once daily at any time of day with or without food. Tablets are to be swallowed whole with half a cup of water for 24 weeks and standard therapy which include either angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB).
  • Active Comparator: Standard therapy which include either ACEI or ARB
    \- The second group (45 patients); will receive the standard therapy (ACEI or ARB).

Primary Outcome Measure

Assessment of the effect of Dapagliflozin on proteinuria. [ Time Frame: Change from Baseline UPCR at 6 months ]

Central Contacts

Related Studies