A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lupus Nephritis
Intervention: tacrolimus capsule (Drug); tacrolimus placebo (Drug); leflunomide tablet (Drug); leflunomide placebo (Drug); prednisone (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
Summary
The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with
leflunomide tablets in the treatment of lupus nephritis.
Clinical Details
Official title: A Randomized, Double-blind Double Dummy, Parallel Control and Multi-center Clinical Trial to Compare the Efficacy and Safety of Tacrolimus Capsules in Treatment of Lupus Nephritis With Leflunomide Tablets
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: remission rate (partial remission + complete remission)
Secondary outcome: urinary protein excretion for 24 hrs (24hr proteinuria)serum albumin level serum creatinine level estimated glomerular filtration rate (eGFR)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- body weight 40-100kg
- diagnosed as systemic lupus erythematosus, (according to American College of
Rheumatology Diagnostic Criteria,1997)
- diagnosed as type III/ IV of lupus nephritis by renal biopsy within 6 months
- 24hr proteinuria ≥2g and/or active urinary sediments
Exclusion Criteria:
- receiving immunosuppressant
- receiving routine treatment of tacrolimus and leflunomide within 1 month
- receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 months before the
study
- history of allergy to tacrolimus and leflunomide
- anticipated maintenance dialysis persisted over 8 weeks; or already being dialyzed
over 2 weeks before recruitment
- planning to receive kidney transplantation or in the near future or having a history
of undergoing kidney transplantation
- serum creatinine (Scr) ≥3mg/dl or estimated glomerular filtration rate (eGFR) <
30ml/min
- diabetes mellitus patients
Locations and Contacts
Beijing, China
Fujian, China
Hubei, China
Hunan, China
Jiangsu, China
Jilin, China
Liaoning, China
Shandong, China
Shanghai, China
Shanxi, China
Sichuan, China
Zhejiang, China
Additional Information
Link to Results on JAPIC - enter 140633 in the JapicCTI-RNo. field
Starting date: April 2011
Last updated: October 15, 2014
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