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

• ClinicalTrials.gov Identifier: NCT01451489
• Recruitment Status: Terminated
• First Posted: October 13, 2011
• Last Update Posted: March 27, 2017
• Sponsor: Nanjing University School of Medicine
• Information provided by (Responsible Party): Zhi-Hong Liu, M.D., Nanjing University School of Medicine

Tracking Information

• First Submitted Date: August 5, 2011
• First Posted Date: October 13, 2011
• Last Update Posted Date: March 27, 2017
• Actual Study Start Date: October 13, 2011
• Actual Primary Completion Date: March 23, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 11, 2011): the rates of the complete remission during the induction phase [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 11, 2011): the total remission rates [ Time Frame: 18 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: FSGS

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 22, 2017): 70
• Original Estimated Enrollment (submitted: October 11, 2011): 130
• Actual Study Completion Date: October 29, 2016
• Actual Primary Completion Date: March 23, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 14 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01451489
• Other Study ID Numbers: NJCT-1101
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Zhi-Hong Liu, M.D., Nanjing University School of Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Nanjing University School of Medicine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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