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

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. |
- lupus nephritis flare [ Time Frame: two years ]
- 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 ]

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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 |
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

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
Contact: Bao Chun De | 086-02158752345 | baochunde_1678@yahoo.com.cn |
China, Shanghai | |
RenJi Hospital | Recruiting |
ShangHai, Shanghai, China, 200001 |
Principal Investigator: | Bao Chun De | RenJi Hospital |
Responsible Party: | BaoChunde, RenJi Hospital |
ClinicalTrials.gov Identifier: | NCT01172002 |
Other Study ID Numbers: |
RenJiH-20100330 |
First Posted: | July 29, 2010 Key Record Dates |
Last Update Posted: | August 11, 2010 |
Last Verified: | August 2010 |
Lupus Nephritis Leflunomide Azathioprine |
Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Azathioprine |
Leflunomide Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Enzyme Inhibitors |