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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 10, 2010
Last Updated Date	August 12, 2011
Start Date ^ICMJE	June 2010
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 10, 2010)	remission of proteinuria [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01084980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 10, 2010)	time to remission, relapse rate, response failure rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Minimal Change Disease
Intervention ^ICMJE	Drug: Tacrolimus tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd Other Name: Prograf
Study Arm (s)	Experimental: Tacrolimus Intervention: Drug: Tacrolimus
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	20
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01084980
Other Study ID Numbers ^ICMJE	MCNS001
Has Data Monitoring Committee	Not Provided
Responsible Party	Suhnggwon Kim, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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