Status:
UNKNOWN
Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Changhai Hospital
Shanghai 10th People's Hospital
Conditions:
Nephritis
Lupus
Eligibility:
All Genders
18-65 years
Phase:
NA
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 cytotoxi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01172002
Start Date
March 1 2010
Last Update
August 11 2010
Active Locations (1)
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1
RenJi Hospital
Shanghai, Shanghai Municipality, China, 200001