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A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy

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ClinicalTrials.gov Identifier: NCT02173106
Recruitment Status : Unknown
Verified June 2014 by Yanhong Deng, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : June 24, 2014
Last Update Posted : July 1, 2014
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University

Brief Summary:
This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy.

Condition or disease Intervention/treatment Phase
Idiopathic Membranous Nephropathy Proteinuria Spontaneous Remission Steroid Nephropathy Cyclosporin Overdose Drug: steroid & Cyclosporin Phase 2

Detailed Description:
Idiopathic membranous nephropathy is a main reason for nephropathy. Since it can get spontaneous remission, in KDIGO, it is recommend that initial therapy should be started only in patients with nephrotic syndrome and when at least the following condition is met:urinary protein excretion persistently exceeds 4g/d and remains at over 50% of the baseline value,and does not show progressive and antiproteinuric therapy during an observation period of at least 6 months. But many retrospective researches reported that using steroids and immunosuppressive agents were better than waiting for spontaneous remission. There were few prospective, randomized, controlled research on whether it is better that begin to use steroids and immunosuppressive agent early without waiting for 6 months. In our study,we evaluate the validity and security of steroids plus cyclosporin therapy in idiopathic membranous nephropathy. This will be a prospective, randomized, controlled, multicenter study. Patients in treatment group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. Patients in control group will waiting for spontaneous remission for 6 months,if there were no spontaneous remissions, patients in control group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. After followed-up for 6 months the curative and side effect of steroid plus cyclosporin therapy in the early stage of idiopathic membranous nephropathy will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Opportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
Study Start Date : June 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Group A: steroid & Cyclosporin
oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months.
Drug: steroid & Cyclosporin
oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months

No Intervention: Group B: no steroid & Cyclosporin
no steroid and cyclosporin and waiting for spontaneous remission for 6 months

Primary Outcome Measures :
  1. Remission of proteinuria (complete or partial) [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation). [ Time Frame: up to 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 14~75 years, regardless of gender without secondary reason, idiopathic membranous nephropathy by renal biopsy
  • Average urinary protein excretion of at least3.5g/24h on two successive examinations,or plasma albumin <30g/l
  • eGFR≥40ml/min/1.73m2
  • Willingness to sign an informed consent

Exclusion Criteria:

  • Secondary membranous nephropathy such as systemic lupus erythematosus, hepatitis B -associated nephritis
  • Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
  • Cirrhosis, chronic active liver disease
  • History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease)
  • Any Active systemic infection or history of serious infection within one month.
  • Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure, chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)
  • Active tuberculosis
  • Known allergy, contraindication or intolerance to the steroids
  • Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception
  • Malignant tumors
  • Excessive drinking or drug abuse
  • Mental aberrations
  • Current or recent (within 30 days) exposure to any other investigational drugs

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): NCT02173106

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Contact: Zongpei Jiang, MD&Ph D 8620-38379727 jx.home@medmail.com.cn

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China, Guangdong
Department of Nephrology,Dongguan People's Hospital Recruiting
Dongguan, Guangdong, China, 523059
Contact: Guohui Liu, MD    86769-28637333    liuguohui5@126.com   
Principal Investigator: Guohui Liu, MD         
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510260
Contact: Jianbo Liang, MD.    8620-34152282    boliangjian@tom.com   
Principal Investigator: Jianbo Liang, MD         
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Zongpei Jiang, MD & Ph. D    8620-38379727    jx.home@medmail.com.cn   
Principal Investigator: Zongpei Jiang, MD & Ph.D         
Department of Nephrology,Huizhou Municipal Central Hospital Recruiting
Huizhou, Guangdong, China, 516001
Contact: Weiqiang Zhong, MD    86752-2288288    13809669766@126.com   
Principal Investigator: Weiqiang Zhong, MD         
Department of Nephrology,1st Affiliated Hospital,Shenzhen University Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Yongcheng He, MD    86755-83366388    heyongcheng@medmail.com.cn   
Principal Investigator: Yongcheng He, MD         
Department of Nephrology,1st People's Hospital of Zhaoqing Recruiting
Zhaoqing, Guangdong, China, 526020
Contact: Jinquan Wu, MD    86758-2832139    zqwujq@163.com   
Principal Investigator: Jinquan Wu, MD         
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Zongpei Jiang, MD &Ph.D The Sixth Affiliated Hospital,Sun Yat-Sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yanhong Deng, The Sixth Affiliated Hospital of Sun Yat-Sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02173106    
Other Study ID Numbers: Usix-IMN-001
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Remission, Spontaneous
Urologic Diseases
Urination Disorders
Urological Manifestations
Autoimmune Diseases
Immune System Diseases
Disease Progression
Disease Attributes
Pathologic Processes
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors