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

NCT ID: NCT01084980

Last Updated: 2011-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-07-31

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.

Conditions

Minimal Change Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus

Group Type: EXPERIMENTAL

Tacrolimus

Intervention Type: DRUG

tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd

Interventions

Tacrolimus

tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd

Intervention Type: DRUG

Other Intervention Names

Prograf

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

MCNS001

Identifier Type: -

Identifier Source: org_study_id