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

This study is currently recruiting participants.
Verified October 2011 by Astellas Pharma Inc
Sponsor:
Collaborator:
Astellas Pharma China, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01342016
First received: April 25, 2011
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Lupus Nephritis
 Drug: tacrolimus capsule
Drug: tacrolimus placebo
Drug: leflunomide tablet
Drug: leflunomide placebo
Drug: prednisone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • remission rate (partial remission + complete remission) [ Time Frame: at 6 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary protein excretion for 24 hrs (24hr proteinuria) [ Time Frame: at 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • serum albumin level [ Time Frame: at 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • serum creatinine level [ Time Frame: at 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • estimated glomerular filtration rate (eGFR) [ Time Frame: at 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: April 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342016

Contacts
Contact: Clinical Development Administration Dept. clinicaltrials_info@jp.astellas.com

Locations
China
Recruiting
Beijing, China
Recruiting
Fujian, China
Recruiting
Hubei, China
Recruiting
Hunan, China
Recruiting
Jiangsu, China
Recruiting
Jilin, China
Recruiting
Liaoning, China
Recruiting
Shandong, China
Recruiting
Shanghai, China
Recruiting
Shanxi, China
Recruiting
Sichuan, China
Recruiting
Zhejiang, China
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma China, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01342016     History of Changes
Other Study ID Numbers: F506-CL-0911
Study First Received: April 25, 2011
Last Updated: October 10, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
prograf
nephritis
leflunomide
immunosuppressant

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Leflunomide
Tacrolimus
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 22, 2013