Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis
|ClinicalTrials.gov Identifier: NCT01328834|
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : November 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Nephritis, Lupus||Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase
Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)
Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment.
Other Name: ADVAGRAF: Tacrolimus Sustained-release Capsules
- Remission rate (complete or partial remission) [ Time Frame: 6 months after therapy ]
- The changes of proteinuria [ Time Frame: every 3 months up to 6 months ]
- 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.
- The changes of 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): NCT01328834
|The First Affiliated Hospital of Sun Yat-sen University IRB|
|Guangzhou, Guangdong, China, 510080|
|Principal Investigator:||Yu Xueqing, MD||Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University|