Kidney FailureNCT01879124
Resistive Index Measurements After Kidney Transplantation
An observational study of Kidney Failure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- How many people
- 346 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2004to Jun 2012
- 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: All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007
Who may be able to join
- Single kidney transplantation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Renal Vascular Resistive Index, Renal Allograft Histology and Outcome
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.
Read the detailed description
Since March 2004, and as part of routine clinical practice, protocol renal allograft biopsies are routinely performed at implantation and at 3, 12 and 24 months after transplantation, in all patients who receive a kidney transplant at the University Hospitals Leuven, unless there is a medical contra-indication or patient refusal to undergo this procedure. The biopsies are scheduled using a dedicated Microsoft Access database ("Biopsy Database"), that is maintained on the central servers of the University Hospitals Leuven. Patients who have an unexplained change in renal allograft function, undergo additional clinically indicated indication biopsies. These biopsies are also recorded in the aforementioned Microsoft Access Database.
All clinical data, including pretransplant donor and recipient characteristics, and post-transplant follow-up data are directly stored and maintained in a prospectively collected electronic database (CCL database until 06/2012, transferred to the central KWS database in 2012). This electronic database is the only existing clinical database for these patients, and contains all clinical patient charts. No written records are collected.
All renal allograft biopsies will be rescored by a single renal pathologist according to the most recent Banff classification, blinded for the clinical parameters and timing of the biopsy. These rescoring data are directly entered in the dedicated Microsoft Access database ("Biopsy Database").
Just prior to performing a renal allograft biopsy with ultrasound guidance, and as part of the routine clinical procedure, duplex measurements are performed by the radiologist who will perform the biopsy. The peak systolic velocity (Vmax) and the minimal diastolic velocity (Vmin) are determined in each patient in two to three representative interlobar arteries. The resistive index is calculated as [1 - (V min/V max)]. This procedure is repeated at three different places in the kidney (lower, interpolar and upper pole). These data are directly entered in the central electronic clinical database system (KWS, see above).
All electronic data will be transferred to a SAS database at time of data extraction.
- Conditions
- Kidney Failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients | All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall renal allograft survival
Measured: 7 years after transplantation
Death-censored graft survival
Measured: 7 years after transplantation
Patient survival
Measured: 7 years after transplantation
Reduction of 50% or more in the eGFR from the value measured at the time of ultrasonography
Measured: 7 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startMar 2004
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Maarten Naesens, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Maarten Naesens, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879124
- Sponsor's protocol ID
- KidneyTX-UZLEUVEN-RI
- Status last verified
- Jun 2013
- First submitted
- 10 Jun 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24195547
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Renal Vascular Resistive Index, Renal Allograft Histology and Outcome
- ClinicalTrials.gov ID
- NCT01879124
- Acronym / sponsor ID
- KidneyTX-UZLEUVEN-RI
- Conditions
- Kidney Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Jun 2013 (estimated)
- 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.
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.
Detailed description
Since March 2004, and as part of routine clinical practice, protocol renal allograft biopsies are routinely performed at implantation and at 3, 12 and 24 months after transplantation, in all patients who receive a kidney transplant at the University Hospitals Leuven, unless there is a medical contra-indication or patient refusal to undergo this procedure. The biopsies are scheduled using a dedicated Microsoft Access database ("Biopsy Database"), that is maintained on the central servers of the University Hospitals Leuven. Patients who have an unexplained change in renal allograft function, undergo additional clinically indicated indication biopsies. These biopsies are also recorded in the aforementioned Microsoft Access Database.
All clinical data, including pretransplant donor and recipient characteristics, and post-transplant follow-up data are directly stored and maintained in a prospectively collected electronic database (CCL database until 06/2012, transferred to the central KWS database in 2012). This electronic database is the only existing clinical database for these patients, and contains all clinical patient charts. No written records are collected.
All renal allograft biopsies will be rescored by a single renal pathologist according to the most recent Banff classification, blinded for the clinical parameters and timing of the biopsy. These rescoring data are directly entered in the dedicated Microsoft Access database ("Biopsy Database").
Just prior to performing a renal allograft biopsy with ultrasound guidance, and as part of the routine clinical procedure, duplex measurements are performed by the radiologist who will perform the biopsy. The peak systolic velocity (Vmax) and the minimal diastolic velocity (Vmin) are determined in each patient in two to three representative interlobar arteries. The resistive index is calculated as [1 - (V min/V max)]. This procedure is repeated at three different places in the kidney (lower, interpolar and upper pole). These data are directly entered in the central electronic clinical database system (KWS, see above).
All electronic data will be transferred to a SAS database at time of data extraction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | – | –All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007
Key inclusion criteria (1 listed)
- Single kidney transplantation
Key exclusion criteria (1 listed)
- None
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
Overall renal allograft survival
Time frame: 7 years after transplantation
Death-censored graft survival
Time frame: 7 years after transplantation
Patient survival
Time frame: 7 years after transplantation
Reduction of 50% or more in the eGFR from the value measured at the time of ultrasonography
Time frame: 7 years after transplantation
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 17 Jun 2013.
- Derived from this study: PubMed 24195547Naesens 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.
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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.
Maarten Naesens, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Failure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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 17 Jun 2013. 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 Belgium. 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?
Overall renal allograft survival (time frame: 7 years after transplantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879124, which also lists 1 linked publication.
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 17 Jun 2013.