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

Phase 2

• Conditions: Lupus Nephritis
• Interventions: Drug: tacrolimus

• Registration Number: NCT00569101
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Status Verified: 2007-12
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Last Update Submitted: 2007-12-04
• Study First Posted: 2007-12-06
• Last Update Posted: 2007-12-06
• Study Completion: 2008-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single	tacrolimus	single arm study (tacrolimus trial group)

Primary Outcome Measures

Name	Time	Method
Reducing proteinuria	6 months

Trial Locations

Locations (1)

SeoulNUH; 🇰🇷 Seoul, Chongno-gu, Korea, Republic of