Back to resultsA Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis
Eligibility Criteria
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
Sites / Locations
- SeoulNUH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single
Arm Description
single arm study (tacrolimus trial group)
Outcomes
Primary Outcome Measures
Reducing proteinuria
Secondary Outcome Measures
Full Information
NCT ID
NCT00569101
First Posted
December 4, 2007
Last Updated
December 4, 2007
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00569101
Brief Title
A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
Official Title
A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single
Arm Type
Experimental
Arm Description
single arm study (tacrolimus trial group)
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Intervention Description
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
Primary Outcome Measure Information:
Title
Reducing proteinuria
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suhnggwon Kim, MD, PhD
Organizational Affiliation
Korea : Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SeoulNUH
City
Seoul
State/Province
Chongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
We'll reach out to this number within 24 hrs