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

This study has been terminated.
(Due to safety concern of active control drug)
Astellas Pharma China, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: April 25, 2011
Last updated: October 15, 2014
Last verified: October 2014
The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.

Condition Intervention Phase
Lupus Nephritis
Drug: tacrolimus capsule
Drug: tacrolimus placebo
Drug: leflunomide tablet
Drug: leflunomide placebo
Drug: prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • remission rate (partial remission + complete remission) [ Time Frame: at 6 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary protein excretion for 24 hrs (24hr proteinuria) [ Time Frame: at 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • serum albumin level [ Time Frame: at 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • serum creatinine level [ Time Frame: at 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • estimated glomerular filtration rate (eGFR) [ Time Frame: at 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: April 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tacrolimus group
tacrolimus capsule + leflunomide placebo
Drug: tacrolimus capsule
Other Names:
  • prograf
  • FK506
Drug: leflunomide placebo
Drug: prednisone
Active Comparator: leflunomide group
tacrolimus placebo + leflunomide tablet
Drug: tacrolimus placebo
Drug: leflunomide tablet
Other Name: airuohua
Drug: prednisone


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342016

Beijing, China
Fujian, China
Hubei, China
Hunan, China
Jiangsu, China
Jilin, China
Liaoning, China
Shandong, China
Shanghai, China
Shanxi, China
Sichuan, China
Zhejiang, China
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma China, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01342016     History of Changes
Other Study ID Numbers: F506-CL-0911 
Study First Received: April 25, 2011
Last Updated: October 15, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Lupus Nephritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Kidney Diseases
Lupus Erythematosus, Systemic
Urologic Diseases
Antirheumatic Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016