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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01342016
Recruitment Status : Terminated (Due to safety concern of active control drug)
First Posted : April 26, 2011
Last Update Posted : October 17, 2014
Astellas Pharma China, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: tacrolimus capsule Drug: tacrolimus placebo Drug: leflunomide tablet Drug: leflunomide placebo Drug: prednisone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. remission rate (partial remission + complete remission) [ Time Frame: at 6 months after treatment ]

Secondary Outcome Measures :
  1. urinary protein excretion for 24 hrs (24hr proteinuria) [ Time Frame: at 12 weeks and 24 weeks ]
  2. serum albumin level [ Time Frame: at 12 weeks and 24 weeks ]
  3. serum creatinine level [ Time Frame: at 12 weeks and 24 weeks ]
  4. estimated glomerular filtration rate (eGFR) [ Time Frame: at 12 weeks and 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01342016     History of Changes
Other Study ID Numbers: F506-CL-0911
First Posted: April 26, 2011    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: October 2014

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Lupus Nephritis
Lupus Erythematosus, Systemic
Kidney Diseases
Urologic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents