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
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01316133
Ages eligible for Study
20 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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)
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
All locations for NCT01316133
Korea, Republic of (7)
Busan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Incheon, Korea, Republic of
Jeonju, Korea, Republic of
Seoul, Korea, Republic of
View full eligibility
Tris trial is registered with FDA with number: NCT01316133. The sponsor of the trial is Astellas Pharma Korea, Inc. and it is looking for 37 volunteers for the current phase.
Official trial title: A Multicenter, Non-comparative, Open-labeled, Prospective Study to Evaluate the Efficacy and Safety of Tacrolimus (Prograf®) With Steroid in Korean Lupus Nephritis Patients Who Are Non-responders to Steroid Monotherapy
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