We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569101
First Posted: December 6, 2007
Last Update Posted: December 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Hospital
December 4, 2007
December 6, 2007
December 6, 2007
September 2007
Not Provided
Reducing proteinuria [ Time Frame: 6 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
The purpose of this protocol is to determine whether Tacrolimus and Prednisolone are effective and safe in the treatment of the cyclophosphamide-resistant, refractory diffuse proliferative lupus nephritis
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lupus Nephritis
Drug: tacrolimus
during the first 2 months : tacrolimus 0.1 mg/kg + prednisolone 0.8 mg/kg p.o. ,then after : tacrolimus 0.1 mg ~0.02 mg/kg + prednisolone tapering
Experimental: single
single arm study (tacrolimus trial group)
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.
 
Unknown status
9
March 2008
Not Provided

Inclusion Criteria:

  • Biopsy-proven lupus nephritis WHO Class IV , IV+V
  • Previously treated by three times over of i.v. cyclophosphamide or 6 months more duration of immunosuppressive treatments (azathioprine, MMF, cyclophosphamide p.o.) for the lupus nephritis
  • spot urine Protein creatinine raio > 1.0
  • RBC > 5 /HPF on microscopic examination of urine

Exclusion Criteria:

  • previous treatment of cyclosporine A or tacrolimus
  • serum Creatinine lever : over 300 mmol/dl
  • allergy to the macrolide antibiotics
  • other systemic organ damage
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00569101
H-0706-049-211
20070217867
Yes
Not Provided
Not Provided
Suhnggwon Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Suhnggwon Kim, MD, PhD Korea : Seoul National University Hospital
Seoul National University Hospital
December 2007

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