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Trial record 1 of 1 for:    NCT 01172002
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Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT01172002
Recruitment Status : Unknown
Verified August 2010 by RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : July 29, 2010
Last Update Posted : August 11, 2010
Sponsor:
Collaborators:
Changhai Hospital
Shanghai 10th People's Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital with Nanjing Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital of Soochow University
Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
Qilu Hospital of Shandong University
AnHui ShengLi Hospital
First Affiliated Hospital Bengbu Medical College
The First Affiliated Hospital of Anhui Medical University
Information provided by:
RenJi Hospital

Tracking Information
First Submitted Date  ICMJE July 27, 2010
First Posted Date  ICMJE July 29, 2010
Last Update Posted Date August 11, 2010
Study Start Date  ICMJE March 2010
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
lupus nephritis flare [ Time Frame: two years ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2010)
Recurrence of lupus nephritis [ Time Frame: two years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
  • 24-hour proteinuria over time [ Time Frame: two years ]
  • Serum albumin over time [ Time Frame: two years ]
  • Number of extra renal flare [ Time Frame: two years ]
  • Cumulated glucocorticoid intake [ Time Frame: two years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2010)
renal disease activity outside, SLEDAI score ≥ 10 [ Time Frame: two years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Official Title  ICMJE A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.
Brief Summary Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Detailed Description Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of this Trial is to compare leflunomide (LEF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis of this trial is that LEF is non-inferior to AZA.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nephritis
  • Lupus
Intervention  ICMJE
  • Drug: Leflunomide

    Leflunomide, 20 mg/d, ORAL ,each day. Number of Cycles: until progression or unacceptable toxicity develops.

    Predonine, 10 mg/d, ORAL, each day. If extra renal flare occurs, the dose of predonine may be increased to 1mg/kg/day for not more than 2 weeks.

  • Drug: Azathioprine

    Azathioprine,50-100 mg/d, ORAL ,each day . Number of Cycles: until progression or unacceptable toxicity develops.

    Predonine, 10 mg/d, ORAL, each day. If extra renal flare occurs, the dose of predonine may be increased to 1mg/kg/day for not more than 2 weeks.

Study Arms  ICMJE
  • Experimental: leflunomide group
    Intervention: Drug: Leflunomide
  • Active Comparator: Azathioprine group
    Intervention: Drug: Azathioprine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 28, 2010)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 to 65 years
  • Biopsy-proven proliferative lupus nephritis
  • Disease activity, SLEDAI score ≥ 8 points
  • Persistent proteinuria (≥ 1g/24h), with or without microscopic hematuria;
  • Signed informed consent

Exclusion Criteria:

  • Allergy to the LEF, CTX, AZA
  • Recent treatment with high-dose glucocorticoids
  • Weight <45kg
  • Recent treatment with immunosuppressive drugs
  • CNS( Central Nerve System) Lupus patients
  • Hepatic failure patients
  • Severely abnormal renal function or end-stage renal failure
  • More exclusion criteria in the protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01172002
Other Study ID Numbers  ICMJE RenJiH-20100330
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BaoChunde, RenJi Hospital
Study Sponsor  ICMJE RenJi Hospital
Collaborators  ICMJE
  • Changhai Hospital
  • Shanghai 10th People's Hospital
  • Shanghai Zhongshan Hospital
  • The First Affiliated Hospital with Nanjing Medical University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of Soochow University
  • Zhejiang University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • First Affiliated Hospital of Wenzhou Medical University
  • Qilu Hospital of Shandong University
  • AnHui ShengLi Hospital
  • First Affiliated Hospital Bengbu Medical College
  • The First Affiliated Hospital of Anhui Medical University
Investigators  ICMJE
Principal Investigator: Bao Chun De RenJi Hospital
PRS Account RenJi Hospital
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP