A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients (APPLE)

Astellas

Status and phase

Terminated

Phase 4

Conditions

Lupus Nephritis

Treatments

Drug: tacrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01316133

PRGLN-10-01-KOR

Details and patient eligibility

About

This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.

Enrollment

37 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
Patients with refractory lupus nephritis
Proteinuria ≥ 0.5 g/day
Patients who took steroid ≥ 20 mg/day over one month prior to the study
Patients who failed a first-line therapy (non-responders to steroid monotherapy)

Exclusion criteria

Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
Patients who received tacrolimus in the past (excluding drugs for external use)
Patients who used other immunosuppressants within 4 weeks before initiation of the study
Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis