NCT01879124

Brief Summary

The purpose of this study is to evaluate the prognostic performance of intrarenal resistive index in the first years after kidney transplantation on graft function and on patient and graft survival. In addition, the determinants of the intrarenal resistive index, including a detailed analysis of the relation between graft histology and the intrarenal resistive index, will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2004

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

8.3 years

First QC Date

June 10, 2013

Last Update Submit

June 12, 2013

Conditions

Kidney Failure

Outcome Measures

Primary Outcomes (4)

  • Overall renal allograft survival

    7 years after transplantation

  • Death-censored graft survival

    7 years after transplantation

  • Patient survival

    7 years after transplantation

  • Reduction of 50% or more in the eGFR from the value measured at the time of ultrasonography

    7 years after transplantation

Study Arms (1)

Kidney transplant recipients

All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007

Eligibility Criteria

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

All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007

You may qualify if:

  • Single kidney transplantation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Naesens M, Heylen L, Lerut E, Claes K, De Wever L, Claus F, Oyen R, Kuypers D, Evenepoel P, Bammens B, Sprangers B, Meijers B, Pirenne J, Monbaliu D, de Jonge H, Metalidis C, De Vusser K, Vanrenterghem Y. Intrarenal resistive index after renal transplantation. N Engl J Med. 2013 Nov 7;369(19):1797-806. doi: 10.1056/NEJMoa1301064.

    PMID: 24195547DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Maarten Naesens, MD PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Maarten Naesens

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 17, 2013

Study Start

March 1, 2004

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations

BE(1)