A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
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ClinicalTrials.gov Identifier: NCT01342016 |
Recruitment Status
:
Terminated
(Due to safety concern of active control drug)
First Posted
: April 26, 2011
Last Update Posted
: October 17, 2014
|
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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 |
Arm | Intervention/treatment |
---|---|
Experimental: tacrolimus group
tacrolimus capsule + leflunomide placebo
|
Drug: tacrolimus capsule
oral
Other Names:
Drug: leflunomide placebo
oral
Drug: prednisone
oral
|
Active Comparator: leflunomide group
tacrolimus placebo + leflunomide tablet
|
Drug: tacrolimus placebo
oral
Drug: leflunomide tablet
oral
Other Name: airuohua
Drug: prednisone
oral
|
- remission rate (partial remission + complete remission) [ Time Frame: at 6 months after treatment ]
- urinary protein excretion for 24 hrs (24hr proteinuria) [ Time Frame: at 12 weeks and 24 weeks ]
- serum albumin level [ Time Frame: at 12 weeks and 24 weeks ]
- serum creatinine level [ Time Frame: at 12 weeks and 24 weeks ]
- estimated glomerular filtration rate (eGFR) [ Time Frame: at 12 weeks and 24 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (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

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 ClinicalTrials.gov identifier (NCT number): NCT01342016
China | |
Beijing, China | |
Fujian, China | |
Hubei, China | |
Hunan, China | |
Jiangsu, China | |
Jilin, China | |
Liaoning, China | |
Shandong, China | |
Shanghai, China | |
Shanxi, China | |
Sichuan, China | |
Zhejiang, China |
Study Chair: | Use Central Contact | Astellas Pharma Inc |
Additional Information:
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov 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:
prograf nephritis leflunomide immunosuppressant |
Additional relevant MeSH terms:
Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Prednisone Tacrolimus Leflunomide Anti-Inflammatory Agents |
Glucocorticoids Hormones 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 |