Status:
COMPLETED
Tacrolimus Versus Cyclophosphamide as Treatment for Lupus Nephritis
Lead Sponsor:
Zhejiang University
Conditions:
SLE
Lupus Nephritis
Eligibility:
All Genders
15-64 years
Phase:
PHASE1
Brief Summary
In this comparative open-label cohort study, the investigators compared the efficacy and safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse proliferative and membranous l...
Detailed Description
Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease. About 60% of SLE patients have renal disease, and patients with rapidly progressive destruction of renal parenchyma have signifi...
Eligibility Criteria
Inclusion
- SLE patients:diagnosis based on American Rheumatism Association criteria;
- renal biopsy-proven active LN (diffuse proliferative and membranous lupus nephritis, class IV, V, V+IV and/or V+III, according to the ISN/RPS 2003 classification13)
- urinary protein excretion of at least 2.0 g per 24 h
- serum creatinine less than 221 µmol/dL (2.5mg/dL)
- creatinine clearance more than 30 mL/min/1.73m2
Exclusion
- pregnant or lactating
- previous treatment with cyclosporine, mycophenolate mofetil treatment for at least two weeks in the previous three months
- known allergies to calcineurin inhibitors
- severe infection or illness
- symptoms of a central nervous system disorder
- alanine aminotransferase more than 100U/L
- evidence of active hepatitis
- fasting blood glucose more than 6.2 mmol/L
- 2 h post-meal blood glucose more than 11.1mmol/L
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01207297
Start Date
March 1 2003
End Date
June 1 2010
Last Update
August 23 2011
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