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

Sun Yat-sen University

Status and phase

Unknown

Phase 2

Conditions

Steroid Nephropathy

Proteinuria

Idiopathic Membranous Nephropathy

Spontaneous Remission

Cyclosporin Overdose

Treatments

Drug: steroid & Cyclosporin

Study type

Interventional

Funder types

Other

Identifiers

NCT02173106

Usix-IMN-001

Details and patient eligibility

About

This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

14 to 75 years old

Volunteers

No Healthy Volunteers

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