Analysis of Foxp3 and Vimentin Expression in Renal Transp... | NCT01443013

Studies
Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient

NCT01443013

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Oct 20, 2015Estimated

Enrollment

266Actual

Phase

Not provided

Conditions

Function of Renal Transplant

Interventions

Renal Transplant

Countries

France

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

ID	Type	Description	Link
AOM09031	Other Identifier	Other sponsor number

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Dec 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Aug 9, 2011

First Submission Date that Met QC Criteria

Sep 28, 2011

First Posted Date

Sep 29, 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

Oct 18, 2015

Last Update Posted Date

Oct 20, 2015Estimated

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 observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

266Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort of Renal Transplant recipients			Other: Renal Transplant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renal Transplant	Other	urinary sample at month 3, 6 and 12	Cohort of Renal Transplant recipients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Foxp3 and Vimentin mRNA expression	evaluation at month 9 suppressed by amendment n°2	at Month 1,3,6 and 12

Secondary Outcomes

Measure	Description	Time Frame
Renal biopsy		at Month 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All renal transplant recipients aged >18 years with informed consent
Kidney transplantation in one of the centers participating in the study all patients registered on the waiting list to the Agency of Biomedicine
Supported by a conventional procedure
Informed consent signed.
No pregnancy or lactation in progress.
Serology HIV and (HCV negative suppressed by amendment n°2)
No contraindication for a biopsy at 1 year post transplant

Exclusion Criteria:

Positive crossmatch, focal segmental glomerulosclerosis (FSGS) as primary nephropathy, HIV positive population
Absence of registration on the waiting list for transplantation with the Agency of Biomedicine
HIV-positive serology
Chronic renal failure secondary to focal segmental hyalinosis
Cross-match historical or cross match of the day positive T or B awareness
Patient included in a Memorandum of industry (suppressed by amendment n°1)
No affiliation to a social security scheme
Patients with early failure due to immediate complications (4%) will be included but will not be considered for analysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All Renal transplant recipients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Philippe Grimbert, MD PHD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Henri Mondor Hospital		Créteil		94010	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18216781	Background	Aquino-Dias EC, Joelsons G, da Silva DM, Berdichevski RH, Ribeiro AR, Veronese FJ, Goncalves LF, Manfro RC. Non-invasive diagnosis of acute rejection in kidney transplants with delayed graft function. Kidney Int. 2008 Apr;73(7):877-84. doi: 10.1038/sj.ki.5002795. Epub 2008 Jan 23.

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016377	Organ Transplantation
D014180	Transplantation