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

A Pilot Study for Comparative Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap®) in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome

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

A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf cap®) in adult patient with minimal change nephritic syndrome.

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