Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• from 18yrs to 80 yrs , man and women

• Minimal change disease is diagnosed by kidney biopsy

• On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0

• On screening, the patient shows that the serum albumin is below 3.0g/dL

• the patient sign on the concent form

Exclusion Criteria:

• the patient have experience to take tacrolimus or cyclosporin for 1 month

• If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day

• steroid dependent or steroid resistant or frequent relapse case

• uncontrolled hypertension

• pregnancy or anticipate pregnancy with 6 month

• hypersensitivity to tacrolimus or macrolide

• acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL