A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy
Opportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
1 other identifier
interventional
180
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2014
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 1, 2014
June 1, 2014
2.5 years
June 23, 2014
June 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Remission of proteinuria (complete or partial)
up to 6 months
Secondary Outcomes (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).
up to 6 months
Study Arms (2)
Group A: steroid & Cyclosporin
EXPERIMENTALoral methylprednisolone 0.4mg/kg/d and 3.5\~5mg/kg/d cyclosporin for 6 months.
Group B: no steroid & Cyclosporin
NO INTERVENTIONno steroid and cyclosporin and waiting for spontaneous remission for 6 months
Interventions
oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Department of Nephrology,Dongguan People's Hospital
Dongguan, Guangdong, 523059, China
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655, China
Department of Nephrology,Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001, China
Department of Nephrology,1st Affiliated Hospital,Shenzhen University
Shenzhen, Guangdong, 518000, China
Department of Nephrology,1st People's Hospital of Zhaoqing
Zhaoqing, Guangdong, 526020, China
Related Publications (1)
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.
PMID: 34778952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zongpei Jiang, MD &Ph.D
The Sixth Affiliated Hospital, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The Sixth Affiliated Hospital of Sun Yat-Sen University
Study Record Dates
First Submitted
June 23, 2014
First Posted
June 24, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
July 1, 2014
Record last verified: 2014-06