Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis
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|ClinicalTrials.gov Identifier: NCT01288664|
Recruitment Status : Withdrawn (sponsor withdraw from this study)
First Posted : February 2, 2011
Last Update Posted : February 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Drug: ADVAGRAF||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months
Tacrolimus Sustained-release Capsules (ADVAGRAF) Started: 0.05-0.1mg/kg/d, one time per day, the blood level:5-10ng/ml in induction phase.
Other Name: ADVAGRAF:Tacrolimus Sustained-release Capsules
- Remission rate (complete or partial remission) [ Time Frame: 6 months ]
- proteinuria [ Time Frame: every 3 months,up to 6 months ]
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores [ Time Frame: every 3 months, up to 6 months ]SLEDAI (Systemic Lupus Erythematosus Disease Activity Index, Bombardier et al, 1992).
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: every 3 months, up to 6 months ]Adverse events,including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc.
- renal function [ Time Frame: every 3 months, up to 6 months ]
- relapse [ Time Frame: every 3 months, up to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288664
|The First Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|
|Principal Investigator:||Yu Xueqing, MD||Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University|