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

NCT ID: NCT02298335

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-13
• Study Completion Date: 2020-10-22

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 nephrotic syndrome.

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 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.

Conditions

Nephrotic Syndrome，Idiopathic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prednisone

First,full-dose induction period, then protracted tapering period.

Group Type: EXPERIMENTAL

prednisone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Zhi-Hong Liu, MD

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhihong Liu, MD

Role: STUDY_CHAIR

Nanjing University School of Medicine

Locations

Research Institute of Nephrology

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NJCT-1401

Identifier Type: -

Identifier Source: org_study_id