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:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT02298335
Eligibility Criteria:
Inclusion Criteria:
* Patients who signed written informed consent form
* Age between 18-65 years, female or male
* Patients with diagnosis of nephrotic syndrome ( proteinuria ≥3.5 g/24h, and serum albumin ≤30g/L ),
* Pathological diagnosis with minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS) and podocyte disease
* Serum creatinine \< 3mg/dl ( 265.2umol/L), estimated glomerular filtration rate(eGFR) no less than 30 ml/min.1.73 m2
Exclusion Criteria:
* Patients who didn't sign written informed consent form
* Patients who have received full-dose prednisone treatment for more than 2 weeks, or pulsed methylprednisolone (\>7.5mg/kg.day) within 2 weeks
* Patients who have taken immunosuppressants within 3 months, as Cyclosporine A, Tacrolimus, Mycophenolate Mofetil, Cyclophosphamide, or Leflunomide etc.
* Patients who have impaired liver function, with Alanine aminotransferase(ALT) or Aspartate aminotransferase(AST) twice more than the normal upper limit, or who have viral hepatitis B with hepatitis B e antigen(HBeAg) positive or hepatitis B virus DNA (HBV-DNA) reduplicative
* Patients who have contraindications to glucocorticoid, for example diabetes, obesity (BMI\>28kg/m2 before disease onset), femoral head necrosis, or active infection.
* Patients who have family history of kidney disease
* Patients who have definite secondary facts of this disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02298335
Study Brief:
Protocol Section:
NCT02298335