NCT03855085

Brief Summary

This study assesses the reproducibility of 3 different formulas in calculating the volume of a transplanted kidney by ultrasound in-vivo measurements. 3 series of measurements will be performed by 2 different operators during the usual ultrasound follow-up of the renal transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

July 25, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

February 25, 2019

Last Update Submit

January 6, 2020

Conditions

Kidney Transplant; Complications

Keywords

Kidney transplantvolumetryultrasound

Outcome Measures

Primary Outcomes (1)

  • Intraclass coefficient of correlation of the ultrasound volume measurement

    The inter-observer and intra-observer variability of the ultrasound volume measurement of the kidney graft will be assessed using the intraclass coefficient of correlation (ICC)

    6 months

Secondary Outcomes (1)

  • Intraclass coefficient of correlation of the volume formula parameters.

    6 months

Eligibility Criteria

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

Kidney transplant recipients

You may qualify if:

  • Kidney transplant recepients with ultrasound follow-up at the University Hospital of Tours
  • Age more than 18 years old

You may not qualify if:

  • Renal deformity of extrinsic origin
  • Early post-transplant period (first 3 days post-transplant)
  • Transplanted organ out of the field of view
  • Dual kidney transplant
  • Opposition to the data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gradinaru

Tours, 37044, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 26, 2019

Study Start

July 25, 2019

Primary Completion

December 17, 2019

Study Completion

December 17, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)