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

NCT02298335 | Completed DMC

• 1 other identifier: NJCT-1401
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrotic Syndrome，Idiopathic

Keywords

Prednisone; idiopathic nephrotic syndrome; prospective

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Secondary Outcomes (1)

• the relapse rate of complete remission participants protracted tapering protocol

  66 weeks

Study Arms (1)

prednisone

EXPERIMENTAL

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

Drug: prednisone

Interventions

prednisone 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.

prednisone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (1)

Research Institute of Nephrology

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Nephrosis, Lipoid

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zhihong Liu, MD

  Nanjing University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: November 21, 2014
• Study Start: May 13, 2014
• Primary Completion: July 1, 2019
• Study Completion: October 22, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

CN (1)