NCT01084980

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 16, 2011

Status Verified

August 1, 2011

Enrollment Period

1.1 years

First QC Date

March 10, 2010

Last Update Submit

August 12, 2011

Conditions

Minimal Change Disease

Keywords

minimal change diseasetacrolimuscorticosteroid

Outcome Measures

Primary Outcomes (1)

  • remission of proteinuria

    12 weeks

Secondary Outcomes (1)

  • time to remission, relapse rate, response failure rate

    12 weeks

Study Arms (1)

Tacrolimus

EXPERIMENTAL
Drug: Tacrolimus

Interventions

TacrolimusDRUG

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

Also known as: Prograf
Tacrolimus

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Nephrosis, Lipoid

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 16, 2011

Record last verified: 2011-08

Locations

KR(1)