Status:
COMPLETED
Glucocorticoid in Treatment of Adult Idiopathic Nephrotic Syndrome：a Prospective Observational Study
Lead Sponsor:
Nanjing University School of Medicine
Conditions:
Nephrotic Syndrome，Idiopathic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is to assess the efficacy and safety of 8-weeks full-dose induction protocol (prednisone 1mg/kg, maximum 60mg/day) and protracted tapering protocol in the treatment of adult idiopathic neph...
Detailed Description
In full-dose induction period, patients scheme to visit at the 4th and 8th week, and in protracted tapering period at 10th , 22nd, 42nd and 66th week. If the patients reach complete remission within 4...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2020
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT02298335
Start Date
May 13 2014
End Date
October 22 2020
Last Update
January 26 2021
Active Locations (1)
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1
Research Institute of Nephrology
Nanjing, Jiangsu, China, 210000