Overview

This trial is active, not recruiting.

Condition lupus nephritis
Treatment tacrolimus
Phase phase 2
Sponsor Seoul National University Hospital
Start date September 2007
End date March 2008
Trial size 9 participants
Trial identifier NCT00569101, 20070217867, H-0706-049-211

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
single arm study (tacrolimus trial group)
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

Primary Outcomes

Measure
Reducing proteinuria
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
Principal investigator Suhnggwon Kim, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2007.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.