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

Primary Purpose

Lupus Nephritis

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
tacrolimus capsule
tacrolimus placebo
leflunomide tablet
leflunomide placebo
prednisone
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring prograf, nephritis, leflunomide, immunosuppressant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tacrolimus group

leflunomide group

Arm Description

tacrolimus capsule + leflunomide placebo

tacrolimus placebo + leflunomide tablet

Outcomes

Primary Outcome Measures

remission rate (partial remission + complete remission)

Secondary Outcome Measures

urinary protein excretion for 24 hrs (24hr proteinuria)
serum albumin level
serum creatinine level
estimated glomerular filtration rate (eGFR)

Full Information

First Posted
April 25, 2011
Last Updated
October 15, 2014
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma China, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01342016
Brief Title
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Due to safety concern of active control drug
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma China, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
prograf, nephritis, leflunomide, immunosuppressant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tacrolimus group
Arm Type
Experimental
Arm Description
tacrolimus capsule + leflunomide placebo
Arm Title
leflunomide group
Arm Type
Active Comparator
Arm Description
tacrolimus placebo + leflunomide tablet
Intervention Type
Drug
Intervention Name(s)
tacrolimus capsule
Other Intervention Name(s)
prograf, FK506
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
tacrolimus placebo
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
leflunomide tablet
Other Intervention Name(s)
airuohua
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
leflunomide placebo
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
oral
Primary Outcome Measure Information:
Title
remission rate (partial remission + complete remission)
Time Frame
at 6 months after treatment
Secondary Outcome Measure Information:
Title
urinary protein excretion for 24 hrs (24hr proteinuria)
Time Frame
at 12 weeks and 24 weeks
Title
serum albumin level
Time Frame
at 12 weeks and 24 weeks
Title
serum creatinine level
Time Frame
at 12 weeks and 24 weeks
Title
estimated glomerular filtration rate (eGFR)
Time Frame
at 12 weeks and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Beijing
Country
China
City
Fujian
Country
China
City
Hubei
Country
China
City
Hunan
Country
China
City
Jiangsu
Country
China
City
Jilin
Country
China
City
Liaoning
Country
China
City
Shandong
Country
China
City
Shanghai
Country
China
City
Shanxi
Country
China
City
Sichuan
Country
China
City
Zhejiang
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140633 in the JapicCTI-RNo. field

Learn more about this trial

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

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