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A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients

Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on February 07, 2013
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: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

Overall contact:
Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com


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)


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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) <


- diabetes mellitus patients

Locations and Contacts

Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com

Beijing, China; Recruiting

Fujian, China; Recruiting

Hubei, China; Recruiting

Hunan, China; Recruiting

Jiangsu, China; Recruiting

Jilin, China; Recruiting

Liaoning, China; Recruiting

Shandong, China; Recruiting

Shanghai, China; Recruiting

Shanxi, China; Recruiting

Sichuan, China; Recruiting

Zhejiang, China; Recruiting

Additional Information

Starting date: April 2011
Last updated: October 10, 2011

Page last updated: February 07, 2013

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