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

Minimal Change Disease Clinical Trial

— MCNS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084980
• Other study ID #: MCNS001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 10, 2010
• Last updated: August 12, 2011
• Start date: June 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Minimal Change Disease
• Nephrosis, Lipoid

Intervention

Drug:
• Tacrolimus
tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission of proteinuria		12 weeks	Yes
Secondary	time to remission, relapse rate, response failure rate		12 weeks	Yes