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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00569101

Enrollment

Registered

2007-12-06

Start date

2007-09-30

Completion date

2008-03-31

Last updated

2007-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

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

Interventions

DRUGtacrolimus

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reducing proteinuria	6 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026