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

Study Description

Brief Summary:

Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Condition or disease	Intervention/treatment	Phase
Nephritis Lupus	Drug: Leflunomide Drug: Azathioprine	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.
Study Start Date :	March 2010
Estimated Primary Completion Date :	June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Azathioprine Azathioprine Sodium Leflunomide

Genetic and Rare Diseases Information Center resources: Glomerulonephritis Lupus Nephritis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: leflunomide group	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.
Active Comparator: Azathioprine group	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.

Outcome Measures

Primary Outcome Measures :

lupus nephritis flare [ Time Frame: two years ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172002

Contacts

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Contact: Bao Chun De	086-02158752345	baochunde_1678@yahoo.com.cn

Locations

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China, Shanghai
RenJi Hospital	Recruiting
ShangHai, Shanghai, China, 200001

Sponsors and Collaborators