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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01342016
Enrollment
84
Registered
2011-04-26
Start date
2011-04-30
Completion date
2013-05-31
Last updated
2014-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

Keywords

prograf, nephritis, leflunomide, immunosuppressant

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.

Interventions

DRUGtacrolimus capsule

oral

DRUGtacrolimus placebo

oral

DRUGleflunomide tablet

oral

DRUGleflunomide placebo

oral

DRUGprednisone

oral

Sponsors

Astellas Pharma China, Inc.
CollaboratorINDUSTRY
Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
remission rate (partial remission + complete remission)at 6 months after treatment

Secondary

MeasureTime frame
urinary protein excretion for 24 hrs (24hr proteinuria)at 12 weeks and 24 weeks
serum albumin levelat 12 weeks and 24 weeks
serum creatinine levelat 12 weeks and 24 weeks
estimated glomerular filtration rate (eGFR)at 12 weeks and 24 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026