Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
- Registration Number
- NCT01084980
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.
- Detailed Description
A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf cap®) in adult patient with minimal change nephritic syndrome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tacrolimus Tacrolimus -
- Primary Outcome Measures
Name Time Method remission of proteinuria 12 weeks
- Secondary Outcome Measures
Name Time Method time to remission, relapse rate, response failure rate 12 weeks
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of