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Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2010 by RenJi Hospital
Sponsor:
Collaborators:
Changhai Hospital
Shanghai 10th People's Hospital
Shanghai Zhongshan Hospital
Jiangsu Province Hospital
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
Wenzhou Medical University
Qilu Hospital
AnHui ShengLi Hospital
First Affiliated Hospital Bengbu Medical College
The First Affiliated Hospital of Anhui Medical University
Information provided by:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT01172002
First received: July 27, 2010
Last updated: August 10, 2010
Last verified: August 2010

July 27, 2010
August 10, 2010
March 2010
June 2018   (final data collection date for primary outcome measure)
lupus nephritis flare [ Time Frame: two years ] [ Designated as safety issue: Yes ]
Recurrence of lupus nephritis [ Time Frame: two years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01172002 on ClinicalTrials.gov Archive Site
  • 24-hour proteinuria over time [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Serum albumin over time [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Number of extra renal flare [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Cumulated glucocorticoid intake [ Time Frame: two years ] [ Designated as safety issue: Yes ]
renal disease activity outside, SLEDAI score ≥ 10 [ Time Frame: two years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.

Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Nephritis
  • Lupus
  • 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.

  • Experimental: leflunomide group
    Intervention: Drug: Leflunomide
  • Active Comparator: Azathioprine group
    Intervention: Drug: Azathioprine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
June 2018   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Bao Chun De 086-02158752345 baochunde_1678@yahoo.com.cn
China
 
NCT01172002
RenJiH-20100330
Yes
BaoChunde, RenJi Hospital
RenJi Hospital
  • Changhai Hospital
  • Shanghai 10th People's Hospital
  • Shanghai Zhongshan Hospital
  • Jiangsu Province Hospital
  • 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
  • Wenzhou Medical University
  • Qilu Hospital
  • AnHui ShengLi Hospital
  • First Affiliated Hospital Bengbu Medical College
  • The First Affiliated Hospital of Anhui Medical University
Principal Investigator: Bao Chun De RenJi Hospital
RenJi Hospital
August 2010

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