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

Primary Purpose

Nephrotic Syndrome，Idiopathic

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

prednisone

About this trial

This is an interventional treatment trial for Nephrotic Syndrome，Idiopathic focused on measuring Prednisone, idiopathic nephrotic syndrome, prospective

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Research Institute of Nephrology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prednisone

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the relapse rate of complete remission participants protracted tapering protocol

Full Information

NCT ID

NCT02298335

First Posted

October 20, 2014

Last Updated

January 24, 2021

Sponsor

Nanjing University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02298335

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

May 13, 2014 (undefined)

Primary Completion Date

July 2019 (Actual)

Study Completion Date

October 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nephrotic Syndrome，Idiopathic

Keywords

Prednisone, idiopathic nephrotic syndrome, prospective

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

235 (Actual)

8. Arms, Groups, and Interventions

Arm Title

prednisone

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

prednisone

Intervention 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.

Primary Outcome Measure Information:

Title

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

the relapse rate of complete remission participants protracted tapering protocol

Time Frame

66 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhihong Liu, MD

Organizational Affiliation

Nanjing University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Research Institute of Nephrology

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

12. IPD Sharing Statement

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

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