Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02298335
Recruitment Status : Active, not recruiting
First Posted : November 21, 2014
Last Update Posted : August 14, 2019
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., 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.

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome,Idiopathic Drug: prednisone Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Observational Study to Assess the Efficacy an Safety of Glucocorticoid Therapy in the Treatment of Adult Idiopathic Nephrotic Syndrome
Study Start Date : June 2014
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: prednisone
First,full-dose induction period, then protracted tapering period.
Drug: prednisone
Full-dose induction period: Prednisone 1mg/, maximum 60mg/day, orally, divided into 3 times; Protracted tapering period: orally, no ask for fract. dos.

Primary Outcome Measures :
  1. the cumulative complete remission rate of 8-weeks full-dose induction protocol [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. the relapse rate of complete remission participants protracted tapering protocol [ Time Frame: 66 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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/ 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02298335

Layout table for location information
China, Jiangsu
Research Institute of Nephrology
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Nanjing University School of Medicine
Layout table for investigator information
Study Chair: Zhihong Liu, MD Nanjing University School of Medicine

Layout table for additonal information
Responsible Party: Zhi-Hong Liu, M.D., Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine Identifier: NCT02298335     History of Changes
Other Study ID Numbers: NJCT-1401
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

Keywords provided by Zhi-Hong Liu, M.D., Nanjing University School of Medicine:
idiopathic nephrotic syndrome

Additional relevant MeSH terms:
Layout table for MeSH terms
Nephrotic Syndrome
Nephrosis, Lipoid
Pathologic Processes
Kidney Diseases
Urologic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents