Status:
UNKNOWN
Effect of Dapagliflozin in Non-Diabetic Patients With Nephrotic Syndrome.
Lead Sponsor:
Ain Shams University
Conditions:
Nephrotic Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
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 hypert...
Detailed Description
Nephrotic syndrome (NS) is a clinical syndrome defined by massive proteinuria (greater than 40 mg/m2 per hour) responsible for hypoalbuminemia (less than 30 g/L), with resulting hyperlipidemia, edema,...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤60 years.
- Patients with diagnosis of nephrotic syndrome (proteinuria ≥3.5g/24hr, and serum albumin ≤30g/L) and Urine protein/Creatinine Ratio (UPCR) ≥2.
- Serum creatinine \<3mg/dl (265.2umol/L) and eGFR \>30 ml/min/1.73 m2.
- Pathological diagnosis with membranous nephropathy (MN) or focal segmental glomerulosclerosis (FSGS).
- Absence of any contraindication to dapagliflozin (eGFR less than 30).
- On a stable dose of an ACEI or ARB for at least 4 weeks prior to randomization or Initiation of ACEI or ARB.
- Agreed to participate and sign written informed consent.
Exclusion
- Diagnosis of type 1 or type 2 diabetes mellitus.
- Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease or lupus nephritis.
- Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- History of severe hypersensitivity or contraindications to dapagliflozin.
- History of repeated urinary tract infection or fungal infection.
- Patients with Hemodynamic instability or Hypotension.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- Pregnancy or breastfeeding.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05966818
Start Date
August 1 2023
End Date
March 1 2024
Last Update
August 1 2023
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