The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis (FSGS)
|ClinicalTrials.gov Identifier: NCT01451489|
Recruitment Status : Terminated (The recruitment of subject is very difficult)
First Posted : October 13, 2011
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|FSGS||Drug: FK506 Drug: Cyclophosphamide||Not Applicable|
- Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients.
- To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis|
|Actual Study Start Date :||October 13, 2011|
|Actual Primary Completion Date :||March 23, 2016|
|Actual Study Completion Date :||October 29, 2016|
Active Comparator: Cyclophosphamide
CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.
Other Name: CTX
0.05-0.1mg/kg/d;adjust the dose according the serum concentration(aim 5-10ng/ml),maximum dose 6mg/day;divided in twice, interval 12 hours.
Other Name: Tacrolimus,Prograf
- the rates of the complete remission during the induction phase [ Time Frame: 6 months ]
- the total remission rates [ Time Frame: 18 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451489
|Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine|
|Nanjing, Jiangsu, China, 210002|
|Study Director:||Zhihong Liu, MD||Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine|