NCT02826811

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 6, 2017

Status Verified

April 1, 2016

Enrollment Period

10 months

First QC Date

June 15, 2016

Last Update Submit

January 5, 2017

Conditions

Graft Dysfunction

Keywords

Graft dysfunctionGraft losskidneyTransplantationBKVAnti-BKVNephropathyImmunosuppressionPrognostic markers

Outcome Measures

Primary Outcomes (1)

  • Quantification of anti-BKV

    up to 12 months post-transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Virologie - Hôpital Civil

Strasbourg, France, 67091, France

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Samira FAFI-KREMER, PharmD, PhD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samira FAFI-KREMER, PharmD, PhD

CONTACT

33.3.69.55.14.38samira.fafi-kremer@unistra.fr

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 6, 2017

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)