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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02173106 |
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Date of registration:
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23/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy
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Scientific title:
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Opportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02173106 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Zongpei Jiang, MD&Ph D |
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Address:
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Telephone:
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8620-38379727 |
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Email:
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jx.home@medmail.com.cn |
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Affiliation:
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Name:
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Zongpei Jiang, MD &Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Sixth Affiliated Hospital,Sun Yat-Sen University |
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Key inclusion & exclusion criteria
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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
Age minimum:
14 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Steroid Nephropathy
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Idiopathic Membranous Nephropathy
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Proteinuria
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Cyclosporin Overdose
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Spontaneous Remission
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Intervention(s)
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Drug: steroid & Cyclosporin
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Primary Outcome(s)
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Remission of proteinuria (complete or partial)
[Time Frame: up to 6 months]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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Usix-IMN-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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