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

October 15, 2014 updated by: Astellas Pharma Inc

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

The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tacrolimus group
tacrolimus capsule + leflunomide placebo
Drug: prednisone
oral
Drug: tacrolimus capsule
oral
Other Names:
  • FK506
  • prograf
Drug: leflunomide placebo
oral
Active Comparator: leflunomide group
tacrolimus placebo + leflunomide tablet
Drug: prednisone
oral
Drug: tacrolimus placebo
oral
Drug: leflunomide tablet
oral
Other Names:
  • airuohua

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
remission rate (partial remission + complete remission)
Time Frame: at 6 months after treatment
at 6 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
urinary protein excretion for 24 hrs (24hr proteinuria)
Time Frame: at 12 weeks and 24 weeks
at 12 weeks and 24 weeks
serum albumin level
Time Frame: at 12 weeks and 24 weeks
at 12 weeks and 24 weeks
serum creatinine level
Time Frame: at 12 weeks and 24 weeks
at 12 weeks and 24 weeks
estimated glomerular filtration rate (eGFR)
Time Frame: at 12 weeks and 24 weeks
at 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma China, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 25, 2011

First Submitted That Met QC Criteria

April 25, 2011

First Posted (Estimate)

April 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 17, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F506-CL-0911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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