Status:
COMPLETED
Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis
Lead Sponsor:
Sun Yat-sen University
Conditions:
Kidney Diseases
Lupus Nephritis
Eligibility:
All Genders
14-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V). To compare the efficacy and s...
Eligibility Criteria
Inclusion
- Subjects of either sex, 14-65 years of age;
- Diagnosis of SLE according to the ACR criteria(1997);
- Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;
- Class IV LN: proteinuria \>1g/24hr or Scr\>115umol/L;
- Class III or V LN: proteinuria \>2g/24hr or Scr\>115umol/L;
- Provision of written informed consent by subject or guardian.
Exclusion
- Inability or unwillingness to provide written informed consent ;
- Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
- Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
- Pregnancy, nursing or use of a non-reliable method of contraception;
- Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
- Previous kidney transplant or planted transplant;
- Scr \> 4mg/dl (353umol/L);
- Active hepatitis, with liver dysfunction;
- Diagnosed DM;
- Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00615173
Start Date
July 1 2006
End Date
September 1 2008
Last Update
October 29 2008
Active Locations (1)
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1
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080