Trial | NCT01172002  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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.
Study Started
Mar 31
2010
Primary Completion
Jun 30
2018
Anticipated
Last Update
Aug 11
2010
Estimate

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.

leflunomide group Experimental

Azathioprine group Active Comparator

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
No Results Posted