The Efficacy and Safety of Tacrolimus in Treated Refracto... | NCT01451489

Studies
The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis

NCT01451489

Sponsor

Nanjing University School of Medicine

Status

Terminated

Last Update Posted

Mar 27, 2017Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

FSGS

Interventions

FK506
Cyclophosphamide

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The recruitment of subject is very difficult

Expanded Access Info

Start Date

Oct 13, 2011Actual

Primary Completion Date

Mar 23, 2016Actual

Completion Date

Oct 29, 2016Actual

First Submitted Date

Aug 5, 2011

First Submission Date that Met QC Criteria

Oct 11, 2011

First Posted Date

Oct 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2017

Last Update Posted Date

Mar 27, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhi-Hong Liu, M.D., Professor, Nanjing University School of MedicinePrincipal Investigator

Lead Sponsor

Nanjing University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cyclophosphamide	Active Comparator	CTX	Drug: Cyclophosphamide
FK506	Experimental	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.	Drug: FK506

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FK506	Drug	FK506:0.05-0.1mg/kg/d	FK506	Tacrolimus,Prograf

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the rates of the complete remission during the induction phase		6 months

Secondary Outcomes

Measure	Description	Time Frame
the total remission rates		18 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhihong Liu, MD	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine		Nanjing	Jiangsu	210002	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35224732	Derived	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.

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D010752	Phosphoramide Mustards