End-stage Renal Disease Clinical Trial
Official title:
Tacrolimus Versus Cyclophosphamide as Treatment for Diffuse Proliferative or Membranous Lupus Nephritis: Prospective Cohort Study
Verified date | September 2010 |
Source | Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China:Chineses Clinical Trial Register |
Study type | Interventional |
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 lupus nephritis with severe renal disease. Treatment of lupus
nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal
function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC.
Methods: Forty patients with diffuse proliferative or membranous were recruited for this
trial, 45% of them had lower Ccr (<60mL/min/1.73m2), 10% had increased serum creatinine
(>180µmol/L) and 67.5% had nephritic proteinuria (>3.5g/day). The investigators compared the
efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC
group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone
followed by azathioprine (50mg/day)for 6 months (CYC group).
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 64 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tacrolimus versus cyclophosphamide as treatment for diffuse proliferative or membranous lupus nephritis | The primary study outcome measure was the cumulative rate of complete remission (CR). | one year | Yes |
Secondary | Evaluating the effective and safety of TAC for severe lupus nephritis compared CYC protocol. | The secondary outcome measure were time required for CR, cumulative rate of sustained remission, relapse rate, immunological parameters, side effects, renal function during treatment and followed-up, and compliance with therapy and TAC dosing and serum levels. | one year | Yes |
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