Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Shanghai Jiao Tong University

Status: Unknown

Conditions: Lupus; Nephritis

Treatments: Drug: Leflunomide; Drug: Azathioprine

Study type: Interventional

Funder types: Other

Identifiers

NCT01172002

RenJiH-20100330

Details and patient eligibility

About

Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

leflunomide group

Experimental group

Treatment:

Drug: Leflunomide

Azathioprine group

Active Comparator group

Treatment:

Drug: Azathioprine