Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | tacrolimus(fk506) treatment in induction and maintenance phase |
|
| 2 | Active Comparator | intravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus (FK506) | Drug | 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; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate | 2006-2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function, proteinuria, relapse. | 2006-2008 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xue Qing Yu, MD | Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Ping Fu, MD | Department of Nephrology, West China Hospital of Sichuan University | Principal Investigator |
| Yun Hua Liao, MD | Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University | Principal Investigator |
| Jin li Zhang, MD | Department of nephrology, People's Hospital of Yunnan Province | Principal Investigator |
| Jian Chen, MD | Department of Nephrology, Fuzhou Military General Hospital | Principal Investigator |
| Tan Qi Lou, MD | Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University | Principal Investigator |
| Yao zhong Kong, MD | Department of Nephrology, 1st People's Hospital of Foshan | Principal Investigator |
| Jun zhou Fu, MD | Department of Nephrology,1st People's Hospital of Guangzhou | Principal Investigator |
| Wei Shi, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Affiliated Hospital, Sun Yet-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21177013 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| cyclophosphamide or azathioprine | Drug | Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d. |
|
| Department of Nephrology, People's Hospital Guangdong Provincial |
| Principal Investigator |
| Zheng rong Liu, MD | Department of Nephrology, Nanfang Hospital of Southern Medical University | Principal Investigator |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D003520 | Cyclophosphamide |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided