A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy
NCT ID: NCT02173106
Last Updated: 2014-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2014-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: steroid & Cyclosporin
oral methylprednisolone 0.4mg/kg/d and 3.5\~5mg/kg/d cyclosporin for 6 months.
steroid & Cyclosporin
oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months
Group B: no steroid & Cyclosporin
no steroid and cyclosporin and waiting for spontaneous remission for 6 months
No interventions assigned to this group
Interventions
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steroid & Cyclosporin
oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yanhong Deng
The Sixth Affiliated Hospital of Sun Yat-Sen University
Principal Investigators
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Zongpei Jiang, MD &Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Sixth Affiliated Hospital, Sun Yat-sen University
Locations
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Department of Nephrology,Dongguan People's Hospital
Dongguan, Guangdong, China
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, China
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Department of Nephrology,Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Department of Nephrology,1st Affiliated Hospital,Shenzhen University
Shenzhen, Guangdong, China
Department of Nephrology,1st People's Hospital of Zhaoqing
Zhaoqing, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Other Identifiers
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Usix-IMN-001
Identifier Type: -
Identifier Source: org_study_id
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