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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02826811

Enrollment

170

Registered

2016-07-11

Start date

2016-07-31

Completion date

2017-05-31

Last updated

2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Dysfunction

Keywords

Graft dysfunction, Graft loss, kidney, Transplantation, BKV, Anti-BKV, Nephropathy, Immunosuppression, Prognostic markers

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.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactSamira FAFI-KREMER, PharmD, PhD

samira.fafi-kremer@unistra.fr33.3.69.55.14.38

Outcome results