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

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

Sponsors

Lead Sponsor: Nanjing University School of Medicine

Source 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.

Overall Status Completed
Start Date 2014-05-13
Completion Date 2020-10-22
Primary Completion Date 2019-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
the cumulative complete remission rate of 8-weeks full-dose induction protocol 8 weeks
Secondary Outcome
Measure Time Frame
the relapse rate of complete remission participants protracted tapering protocol 66 weeks
Enrollment 235
Condition
Intervention

Intervention Type: Drug

Intervention Name: prednisone

Description: 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.

Arm Group Label: prednisone

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Zhihong Liu, MD Study Chair Nanjing University School of Medicine
Location
Facility: Research Institute of Nephrology
Location Countries

China

Verification Date

2021-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Nanjing University School of Medicine

Investigator Full Name: Zhi-Hong Liu, MD

Investigator Title: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: prednisone

Type: Experimental

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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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