Kidney Transplant; ComplicationsNCT03855085
Kidney Transplant Volumetry
An observational study of Kidney Transplant; Complications, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2019to 17 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant recipients
Who may be able to join
- Kidney transplant recepients with ultrasound follow-up at the University Hospital of Tours
- Age more than 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Reproducibility of Kidney Transplant Sonographic Volume Measurement
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.
Read the detailed description
The 3 series of measurements
- Longitudinal section: maximum longitudinal length, width at the hilum, maximum width, width at the upper third, longitudinal cross-sectional area
- Transverse section at the hilum : thickness, width, hilar cross-sectional area
- Largest transverse section : thickness, width, maximum transverse cross-sectional area
Clinical and biological patient data collection:
age, gender, date of transplantation, serum creatinine and glomerular filtration rate (GFR), kidney transplant placement (right or left iliac fossa), acute illness or usual follow-up
- Conditions
- Kidney Transplant; Complications
- Keywords
- Kidney transplant, volumetry, ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
Intraclass coefficient of correlation of the volume formula parameters.
The reproducibility of each formula parameter will also be assessed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start25 Jul 2019
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855085
- Sponsor's protocol ID
- RIPH3-RNI19-Volumetrie GreffeR
- Status last verified
- Jan 2020
- First submitted
- 25 Feb 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Reproducibility of Kidney Transplant Sonographic Volume Measurement
- ClinicalTrials.gov ID
- NCT03855085
- Acronym / sponsor ID
- RIPH3-RNI19-Volumetrie GreffeR
- Conditions
- Kidney Transplant; Complications
- Keywords
- Kidney transplant, volumetry, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The 3 series of measurements
- Longitudinal section: maximum longitudinal length, width at the hilum, maximum width, width at the upper third, longitudinal cross-sectional area
- Transverse section at the hilum : thickness, width, hilar cross-sectional area
- Largest transverse section : thickness, width, maximum transverse cross-sectional area
Clinical and biological patient data collection:
age, gender, date of transplantation, serum creatinine and glomerular filtration rate (GFR), kidney transplant placement (right or left iliac fossa), acute illness or usual follow-up
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients
Key inclusion criteria (2 listed)
- Kidney transplant recepients with ultrasound follow-up at the University Hospital of Tours
- Age more than 18 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraclass coefficient of correlation of the ultrasound volume measurement
Time frame: 6 months
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)
1 secondary outcome
Intraclass coefficient of correlation of the volume formula parameters.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant; Complications, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraclass coefficient of correlation of the ultrasound volume measurement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.