Clinical trial NCT00615173: Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Diseases
Lupus Nephritis
Tacrolimus
Induction Phase
Maintenance Phase
Keywords: Tacrolimus
lupus nephritis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 81
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).


Eligibility criteria: Inclusion Criteria:

1. Subjects of either sex, 14-65 years of age;
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:

1. Inability or unwillingness to provide written informed consent ;
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 .

Primary outcomes:
measure: Remission rate
timeFrame: 2006-2008
Secondary outcomes:
measure: Renal function, proteinuria, relapse.
timeFrame: 2006-2008
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
affiliation: Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
name: Xue Qing Yu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, West China Hospital of Sichuan University
name: Ping Fu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University
name: Yun Hua Liao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of nephrology, People's Hospital of Yunnan Province
name: Jin li Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, Fuzhou Military General Hospital
name: Jian Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
name: Tan Qi Lou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 1st People's Hospital of Foshan
name: Yao zhong Kong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology,1st People's Hospital of Guangzhou
name: Jun zhou Fu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, People's Hospital Guangdong Provincial
name: Wei Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, Nanfang Hospital of Southern Medical University
name: Zheng rong Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.