A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cyclosporine; Cyclosporins; Methylprednisolone

Criteria

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