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

Study Locations

  • China
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Recruiting
        • Department of Nephrology,Dongguan People's Hospital
        • Contact:
        • Principal Investigator:
          • Guohui Liu, MD
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • Jianbo Liang, MD
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Zongpei Jiang, MD & Ph.D
      • Huizhou, Guangdong, China, 516001
        • Recruiting
        • Department of Nephrology,Huizhou Municipal Central Hospital
        • Contact:
        • Principal Investigator:
          • Weiqiang Zhong, MD
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Department of Nephrology,1st Affiliated Hospital,Shenzhen University
        • Contact:
        • Principal Investigator:
          • Yongcheng He, MD
      • Zhaoqing, Guangdong, China, 526020
        • Recruiting
        • Department of Nephrology,1st People's Hospital of Zhaoqing
        • Contact:
        • 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.
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

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

Sun Yat-sen University

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.

General Publications

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

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.

Clinical Trials on Proteinuria

Clinical Trials on steroid & Cyclosporin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe