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

Lupus Nephritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01342016
• Other study ID #: F506-CL-0911
• Status: Terminated
• Phase: Phase 3
• First received: April 25, 2011
• Last updated: October 15, 2014
• Start date: April 2011
• Est. completion date: May 2013

Study information

• Verified date: October 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• tacrolimus capsule
oral
• tacrolimus placebo
oral
• leflunomide tablet
oral
• leflunomide placebo
oral
• prednisone
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission rate (partial remission + complete remission)		at 6 months after treatment	No
Secondary	urinary protein excretion for 24 hrs (24hr proteinuria)		at 12 weeks and 24 weeks	No
Secondary	serum albumin level		at 12 weeks and 24 weeks	No
Secondary	serum creatinine level		at 12 weeks and 24 weeks	No
Secondary	estimated glomerular filtration rate (eGFR)		at 12 weeks and 24 weeks	No

External Links

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