Role of Anti-BK Virus Neutralizing Antibodies (BKV) as a... | NCT02826811

Studies
Role of Anti-BK Virus Neutralizing Antibodies (BKV) as a Prognostic Marker for the Development of Nephropathy BK

NCT02826811

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jan 6, 2017Estimated

Enrollment

170Estimated

Phase

Not provided

Conditions

Graft Dysfunction

Interventions

Not provided

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

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

May 2017Estimated

Completion Date

May 2017Estimated

First Submitted Date

Jun 15, 2016

First Submission Date that Met QC Criteria

Jul 7, 2016

First Posted Date

Jul 11, 2016Estimated

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

Jan 5, 2017

Last Update Posted Date

Jan 6, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

BKV nephropathy (BKV) is one of the most frequent complications of kidney transplantation.

In the absence of specific anti-BKV treatment, pre-emptive reduction of immunosuppression is the main strategy that has proven effective in reducing the risk of BKVN. However, it exposes a transplant rejection risk estimated between 4 and 14% according to studies.

Despite the pre-emptive reduction of immunosuppression, a significant number of patients continue to progress towards BKVN suggesting that pre-emptive strategy is late. It's therefore urgent to develop new prognostic markers to identify earlier and more effectively patients with a higher risk of developing BKVN.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

170Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantification of anti-BKV		up to 12 months post-transplantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient over 18 years
Grafted kidney patient between 1 July 2012 and 31 July 2014 at Strasbourg University Hospital with regular monitoring

Exclusion Criteria:

Patient under 18 years

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

Kidney transplant patients between 1 July 2012 and 31 July 2014 at the University Hospital of Strasbourg

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samira FAFI-KREMER, PharmD, PhD	Contact	33.3.69.55.14.38		samira.fafi-kremer@unistra.fr

Overall Officials

Name	Affiliation	Role
Samira FAFI-KREMER, PharmD, PhD	University Hospital, Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Virologie - Hôpital Civil	Recruiting	Strasbourg	France	67091	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided