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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: tacrolimus group; tacrolimus capsule + leflunomide placebo	Drug: tacrolimus capsule; oral; Other Names: prograf; FK506 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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Link to Results on JAPIC - enter 140633 in the JapicCTI-RNo. field 

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01342016 History of Changes
Other Study ID Numbers:	F506-CL-0911
First Posted:	April 26, 2011
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