Glucocorticoid in Treatment of Adult Idiopathic Nephrotic Syndrome：a Prospective Observational Study

Nephrotic Syndrome,Idiopathic Clinical Trial

Official title:

A Prospective Observational Study to Assess the Efficacy an Safety of Glucocorticoid Therapy in the Treatment of Adult Idiopathic Nephrotic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298335
• Other study ID #: NJCT-1401
• Status: Completed
• Phase: N/A
• Start date: May 13, 2014
• Est. completion date: October 22, 2020

Study information

• Verified date: January 2021
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 nephrotic syndrome.

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 weeks, prednisone may be decreased at the 6th week, otherwise keep on the course to the 8th week. All patients reach complete remission will shift to protracted tapering period and follow up until prednisone withdrawal, except the cases that relapse and drop out the study. If proteinuria reappears in someone, angiotensin-converting enzyme inhibitor（ACEI） or angiotensin receptor blocker（ARB） will be considered combination, on the premise of the blood pressure is affordable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: October 22, 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Nephrotic Syndrome,Idiopathic
• Syndrome

Intervention

Drug:
• prednisone
Full-dose induction period: Prednisone 1mg/kg.day, maximum 60mg/day, orally, divided into 3 times; Protracted tapering period: orally, no ask for fract. dos.

Locations

Country	Name	City	State
China	Research Institute of Nephrology	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the cumulative complete remission rate of 8-weeks full-dose induction protocol		8 weeks
Secondary	the relapse rate of complete remission participants protracted tapering protocol		66 weeks