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

Phase 2

Completed

• Conditions: Minimal Change Disease
• Interventions: Drug: Tacrolimus

• 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.

Study Timeline

• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Study Start: 2010-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-12
• Last Update Posted: 2011-08-16

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