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)
Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma China, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01342016
First received: April 25, 2011
Last updated: October 15, 2014
Last verified: October 2014
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Purpose
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
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342016
Locations
| 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 | |
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma China, Inc.
Investigators
| Study Chair: | Use Central Contact | Astellas Pharma Inc |
More Information
Additional Information:
No publications provided
| 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:
|
prograf nephritis leflunomide immunosuppressant |
Additional relevant MeSH terms:
|
Lupus Nephritis Nephritis Autoimmune Diseases Connective Tissue Diseases Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Urologic Diseases Leflunomide |
Tacrolimus Antirheumatic Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015