Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Primary Purpose
Nephritis, Lupus
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Leflunomide
Azathioprine
Sponsored by
About this trial
This is an interventional treatment trial for Nephritis focused on measuring Lupus Nephritis, Leflunomide, Azathioprine
Eligibility Criteria
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
Sites / Locations
- RenJi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
leflunomide group
Azathioprine group
Arm Description
Outcomes
Primary Outcome Measures
lupus nephritis flare
Secondary Outcome Measures
24-hour proteinuria over time
Serum albumin over time
Number of extra renal flare
Cumulated glucocorticoid intake
Full Information
NCT ID
NCT01172002
First Posted
July 27, 2010
Last Updated
August 10, 2010
Sponsor
RenJi Hospital
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
1. Study Identification
Unique Protocol Identification Number
NCT01172002
Brief Title
Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Official Title
A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
RenJi Hospital
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephritis, Lupus
Keywords
Lupus Nephritis, Leflunomide, Azathioprine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
leflunomide group
Arm Type
Experimental
Arm Title
Azathioprine group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Intervention Description
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.
Primary Outcome Measure Information:
Title
lupus nephritis flare
Time Frame
two years
Secondary Outcome Measure Information:
Title
24-hour proteinuria over time
Time Frame
two years
Title
Serum albumin over time
Time Frame
two years
Title
Number of extra renal flare
Time Frame
two years
Title
Cumulated glucocorticoid intake
Time Frame
two years
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bao Chun De
Phone
086-02158752345
Email
baochunde_1678@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bao Chun De
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RenJi Hospital
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
35788493
Citation
Fu Q, Wu C, Dai M, Wang S, Xu J, Dai L, Li Z, He L, Zhu X, Sun L, Lu L, Bao C. Leflunomide versus azathioprine for maintenance therapy of lupus nephritis: a prospective, multicentre, randomised trial and long-term follow-up. Ann Rheum Dis. 2022 Nov;81(11):1549-1555. doi: 10.1136/ard-2022-222486. Epub 2022 Jul 4.
Results Reference
derived
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Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
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