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

Phase 4

Terminated

• Conditions: Lupus Nephritis
• Interventions: Drug: tacrolimus

• Registration Number: NCT01316133
• Lead Sponsor: Astellas Pharma Korea, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-16
• Study Start: 2011-04-19
• Primary Completion: 2016-04-08
• Study Completion: 2016-04-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus group	tacrolimus	Oral

Primary Outcome Measures

Name	Time	Method
Remission rate	24 weeks	Percentage of the patients who shows complete remission or partial remission

Secondary Outcome Measures

Name	Time	Method
Change from baseline in urine protein to creatinine ratio	Baseline, 4 weeks, 12 weeks and 24 weeks
Change from baseline in serum creatinine	Baseline, 4 weeks, 12 weeks and 24 weeks
Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs	for 24 weeks
Complete remission rate	24 weeks