We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis (FSGS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine

Tracking Information
First Submitted Date  ICMJE August 5, 2011
First Posted Date  ICMJE October 13, 2011
Last Update Posted Date March 27, 2017
Actual Study Start Date  ICMJE October 13, 2011
Actual Primary Completion Date March 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
the rates of the complete remission during the induction phase [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
the total remission rates [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis
Official Title  ICMJE A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis
Brief Summary This is a prospective,multicentre study to compare the efficacy, safety, tolerability and relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis (FSGS).
Detailed Description
  1. Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients.
  2. To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE FSGS
Intervention  ICMJE
  • Drug: FK506
    FK506:0.05-0.1mg/kg/d
    Other Name: Tacrolimus,Prograf
  • Drug: 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
Study Arms  ICMJE
  • Active Comparator: Cyclophosphamide
    CTX
    Intervention: Drug: Cyclophosphamide
  • Experimental: FK506
    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.
    Intervention: Drug: FK506
Publications * Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 22, 2017)
70
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2011)
130
Actual Study Completion Date  ICMJE October 29, 2016
Actual Primary Completion Date March 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with a diagnosis of FSGS.
  • Patients with a proteinuria ≥ 3.5g/24h,and blood albumin <30g/L,and Scr< 2.3 mg/dl and eGFR>30ml/min per 1.73m2.
  • Patients who signed written informed consent form (patients less than 18 years old with their parents/legal representative's signatures), and have given their consent to follow all study procedures and follow-up.

Exclusion Criteria:

  • Patients who have received treatment of FK506 in latest 2 month or the cumulative dose CTX≥6 g.
  • Patients who are known to be allergic to a macrolide.
  • Patients who have active hepatitis.
  • Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit .
  • Patients with blood leukocyte < 3000/ul.
  • Patients with kidney disease family history
  • Patients with 2 type diabetes.
  • Patients with obesity whose BMI>28kg/m2.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01451489
Other Study ID Numbers  ICMJE NJCT-1101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Zhi-Hong Liu, M.D., Nanjing University School of Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nanjing University School of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Zhihong Liu, MD Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
PRS Account Nanjing University School of Medicine
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP