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

Seoul National University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Minimal Change Disease

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT01084980

MCNS001

Details and patient eligibility

About

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

Full description

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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