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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01084980
First received: March 10, 2010
Last updated: August 12, 2011
Last verified: August 2011

March 10, 2010
August 12, 2011
June 2010
July 2011   (final data collection date for primary outcome measure)
remission of proteinuria [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01084980 on ClinicalTrials.gov Archive Site
time to remission, relapse rate, response failure rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf cap®) in adult patient with minimal change nephritic syndrome.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Minimal Change Disease
Drug: Tacrolimus
tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd
Other Name: Prograf
Experimental: Tacrolimus
Intervention: Drug: Tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01084980
MCNS001
Not Provided
Suhnggwon Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP