- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02173106
A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy
June 30, 2014 updated by: Yanhong Deng, Sun Yat-sen University
Opportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zongpei Jiang, MD&Ph D
- Phone Number: 8620-38379727
- Email: jx.home@medmail.com.cn
Study Locations
-
-
Guangdong
-
Dongguan, Guangdong, China, 523059
- Recruiting
- Department of Nephrology,Dongguan People's Hospital
-
Contact:
- Guohui Liu, MD
- Phone Number: 86769-28637333
- Email: liuguohui5@126.com
-
Principal Investigator:
- Guohui Liu, MD
-
Guangzhou, Guangdong, China, 510260
- Recruiting
- Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
-
Contact:
- Jianbo Liang, MD.
- Phone Number: 8620-34152282
- Email: boliangjian@tom.com
-
Principal Investigator:
- Jianbo Liang, MD
-
Guangzhou, Guangdong, China, 510655
- Recruiting
- Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
-
Contact:
- Zongpei Jiang, MD & Ph. D
- Phone Number: 8620-38379727
- Email: jx.home@medmail.com.cn
-
Principal Investigator:
- Zongpei Jiang, MD & Ph.D
-
Huizhou, Guangdong, China, 516001
- Recruiting
- Department of Nephrology,Huizhou Municipal Central Hospital
-
Contact:
- Weiqiang Zhong, MD
- Phone Number: 86752-2288288
- Email: 13809669766@126.com
-
Principal Investigator:
- Weiqiang Zhong, MD
-
Shenzhen, Guangdong, China, 518000
- Recruiting
- Department of Nephrology,1st Affiliated Hospital,Shenzhen University
-
Contact:
- Yongcheng He, MD
- Phone Number: 86755-83366388
- Email: heyongcheng@medmail.com.cn
-
Principal Investigator:
- Yongcheng He, MD
-
Zhaoqing, Guangdong, China, 526020
- Recruiting
- Department of Nephrology,1st People's Hospital of Zhaoqing
-
Contact:
- Jinquan Wu, MD
- Phone Number: 86758-2832139
- Email: zqwujq@163.com
-
Principal Investigator:
- Jinquan Wu, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: steroid & Cyclosporin
oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Remission of proteinuria (complete or partial)
Time Frame: up to 6 months
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zongpei Jiang, MD &Ph.D, The Sixth Affiliated Hospital,Sun Yat-Sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
June 23, 2014
First Submitted That Met QC Criteria
June 23, 2014
First Posted (Estimate)
June 24, 2014
Study Record Updates
Last Update Posted (Estimate)
July 1, 2014
Last Update Submitted That Met QC Criteria
June 30, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Urologic Diseases
- Urological Manifestations
- Disease Attributes
- Urination Disorders
- Nephritis
- Glomerulonephritis
- Disease Progression
- Kidney Diseases
- Proteinuria
- Glomerulonephritis, Membranous
- Remission, Spontaneous
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- Usix-IMN-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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