NCT02173106

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Idiopathic Membranous Nephropathy
• Proteinuria
• Spontaneous Remission
• Steroid Nephropathy
• Cyclosporin Overdose

Interventions

Type	Name	Description
DRUG	steroid & Cyclosporin	oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-06-24
• Last updated: 2014-07-01

Locations

6 sites across 1 country: China