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
  Purpose

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


Condition Intervention Phase
Minimal Change Disease
Drug: Tacrolimus
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • remission of proteinuria [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time to remission, relapse rate, response failure rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus Drug: Tacrolimus
tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd
Other Name: Prograf

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084980

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Suhnggwon Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01084980     History of Changes
Other Study ID Numbers: MCNS001
Study First Received: March 10, 2010
Last Updated: August 12, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
minimal change disease
tacrolimus
corticosteroid

Additional relevant MeSH terms:
Nephrosis, Lipoid
Nephrosis
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014