Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis
NCT ID: NCT00615173
Last Updated: 2008-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
81 participants
INTERVENTIONAL
2006-07-31
2008-09-30
Brief Summary
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To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
tacrolimus(fk506) treatment in induction and maintenance phase
tacrolimus (FK506)
Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
2
intravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase
cyclophosphamide or azathioprine
Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.
Interventions
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tacrolimus (FK506)
Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
cyclophosphamide or azathioprine
Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of SLE according to the ACR criteria(1997);
3. Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;
4. Class IV LN: proteinuria \>1g/24hr or Scr\>115umol/L;
5. Class III or V LN: proteinuria \>2g/24hr or Scr\>115umol/L;
6. Provision of written informed consent by subject or guardian.
Exclusion Criteria
2. Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
3. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
4. Pregnancy, nursing or use of a non-reliable method of contraception;
5. 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;
6. Previous kidney transplant or planted transplant;
7. Scr \> 4mg/dl (353umol/L);
8. Active hepatitis, with liver dysfunction;
9. Diagnosed DM;
10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
14 Years
65 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Sun Yat-sen University
Principal Investigators
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Xue Qing Yu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Ping Fu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, West China Hospital of Sichuan University
Yun Hua Liao, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University
Jin li Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Department of nephrology, People's Hospital of Yunnan Province
Jian Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, Fuzhou Military General Hospital
Tan Qi Lou, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
Yao zhong Kong, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, 1st People's Hospital of Foshan
Jun zhou Fu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology,1st People's Hospital of Guangzhou
Wei Shi, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, People's Hospital Guangdong Provincial
Zheng rong Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, Nanfang Hospital of Southern Medical University
Locations
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The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China
Countries
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References
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Chen W, Tang X, Liu Q, Chen W, Fu P, Liu F, Liao Y, Yang Z, Zhang J, Chen J, Lou T, Fu J, Kong Y, Liu Z, Fan A, Rao S, Li Z, Yu X. Short-term outcomes of induction therapy with tacrolimus versus cyclophosphamide for active lupus nephritis: A multicenter randomized clinical trial. Am J Kidney Dis. 2011 Feb;57(2):235-44. doi: 10.1053/j.ajkd.2010.08.036. Epub 2010 Dec 21.
Other Identifiers
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SYSU-PRGLN-001
Identifier Type: -
Identifier Source: org_study_id