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

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ClinicalTrials.gov Identifier: NCT02298335
Recruitment Status : Unknown
Verified August 2016 by Zhi-Hong Liu, M.D., Nanjing University School of Medicine.
Recruitment status was:  Recruiting
First Posted : November 21, 2014
Last Update Posted : August 11, 2016
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2018

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/kg.day, 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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02298335


Contacts
Contact: Haitao Zhang, MD 86-25-80861312 htzhang163@163.com

Locations
China, Jiangsu
Research Institute of Nephrology Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Haitao Zhang, MD    86-25-80861312    htzhang163@163.com   
Contact: Minlin Zhou, MD    86-25-80863791    zminlin@163.com   
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Study Chair: Zhihong Liu, MD Nanjing University School of Medicine

Responsible Party: Zhi-Hong Liu, M.D., Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT02298335     History of Changes
Other Study ID Numbers: NJCT-1401
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

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

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