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

Graft Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02826811
• Other study ID #: 6368
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2016
• Last updated: January 5, 2017
• Start date: July 2016
• Est. completion date: May 2017

Study information

• Verified date: April 2016
• Source: University Hospital, Strasbourg, France
• Contact: Samira FAFI-KREMER, PharmD, PhD
• Phone: 33.3.69.55.14.38
• Email: samira.fafi-kremer[@]unistra.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Graft Dysfunction
• Kidney Diseases

Locations

Country	Name	City	State
France	Service de Virologie - Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of anti-BKV		up to 12 months post-transplantation	No