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

Seoul National University Hospital9 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lupus Nephritis

Interventions

tacrolimusDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

SeoulNUH

Seoul, Chongno-gu, South Korea

Outcomes

Primary Outcomes

Reducing proteinuria

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.