Back to resultsTherapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome (MCNS)
Primary Purpose
Minimal Change Disease
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Minimal Change Disease focused on measuring minimal change disease, tacrolimus, corticosteroid
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tacrolimus
Arm Description
Outcomes
Primary Outcome Measures
remission of proteinuria
Secondary Outcome Measures
time to remission, relapse rate, response failure rate
Full Information
NCT ID
NCT01084980
First Posted
March 10, 2010
Last Updated
August 12, 2011
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01084980
Brief Title
Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Change Disease
Keywords
minimal change disease, tacrolimus, corticosteroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Prograf
Intervention Description
tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd
Primary Outcome Measure Information:
Title
remission of proteinuria
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
time to remission, relapse rate, response failure rate
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
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