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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01084980

Acronym

MCNS

Enrollment

Registered

2010-03-11

Start date

2010-06-30

Completion date

2011-07-31

Last updated

2011-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimal Change Disease

Keywords

minimal change disease, tacrolimus, corticosteroid

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.

Interventions

DRUGTacrolimus

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
remission of proteinuria	12 weeks

Secondary

Measure	Time frame
time to remission, relapse rate, response failure rate	12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026