Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT05966818
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05966818
Study Brief:
Protocol Section:
NCT05966818