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

NCT ID: NCT02826811

Last Updated: 2017-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-05-31

Brief Summary

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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

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Conditions

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Graft Dysfunction

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samira FAFI-KREMER, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

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Service de Virologie - Hôpital Civil

Strasbourg, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Samira FAFI-KREMER, PharmD, PhD

Role: CONTACT

33.3.69.55.14.38

Facility Contacts

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Samira FAFI-KREMER, PharmD, PhD

Role: primary

33.3.69.55.14.38

Other Identifiers

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6368

Identifier Type: -

Identifier Source: org_study_id

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