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

Primary Purpose

FSGS

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FK506
Cyclophosphamide
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for FSGS focused on measuring FSGS, FK506, CTX

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cyclophosphamide

FK506

Arm Description

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.

Outcomes

Primary Outcome Measures

the rates of the complete remission during the induction phase

Secondary Outcome Measures

the total remission rates

Full Information

First Posted
August 5, 2011
Last Updated
March 22, 2017
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01451489
Brief Title
The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis
Acronym
FSGS
Official Title
A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
The recruitment of subject is very difficult
Study Start Date
October 13, 2011 (Actual)
Primary Completion Date
March 23, 2016 (Actual)
Study Completion Date
October 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FSGS
Keywords
FSGS, FK506, CTX

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclophosphamide
Arm Type
Active Comparator
Arm Description
CTX
Arm Title
FK506
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
FK506
Other Intervention Name(s)
Tacrolimus,Prograf
Intervention Description
FK506:0.05-0.1mg/kg/d
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
CTX
Intervention Description
CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.
Primary Outcome Measure Information:
Title
the rates of the complete remission during the induction phase
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the total remission rates
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, MD
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35224732
Citation
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.
Results Reference
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The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis

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