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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
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


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

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

Page last updated: August 23, 2015

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