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

Not Applicable

Completed

• Conditions: Nephrotic Syndrome，Idiopathic
• Interventions: Drug: prednisone

• Registration Number: NCT02298335
• Lead Sponsor: Nanjing University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-05-13
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Primary Completion: 2019-07
• Study Completion: 2020-10-22
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prednisone	prednisone	First,full-dose induction period, then protracted tapering period.

Primary Outcome Measures

Name	Time	Method
the cumulative complete remission rate of 8-weeks full-dose induction protocol	8 weeks

Secondary Outcome Measures

Name	Time	Method
the relapse rate of complete remission participants protracted tapering protocol	66 weeks

Trial Locations

Locations (1)

Research Institute of Nephrology; 🇨🇳 Nanjing, Jiangsu, China