Kidney TransplantationNCT03764124
Observation Study for Prediction of Allograft Survival and Impact of Imaging in Kidney Transplant Recipients.
An observational study of Kidney Transplantation, run by University of Liege at 1 site in Belgium.
Trial summary
To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, and help clinical decision-making. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- PET/CT imaging
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2007to Aug 2024
- 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 recipients aged over 18 of all sexes recruited between 2007 and 2020 from the Centre Hospitalier Universitaire of Liege, who have e-GFR follow-up and data from protocol and for cause biopsies available at 1-year post transplant. PET/CT imaging will be performed with patient's approval for protocol and per cause biopsies we performed. Data will be collected in the follow up such as clinical, biological and histological data.
Who may be able to join
- Kidney recipient transplanted after 2007
- Kidney recipient over 18 years of age
- Clinical, biological, immunological and follow up data available
Who cannot join
- Combined transplantation
Trial locations and contacts
1 site in 1 country.
Laurent Weekers, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
Antoine Bouquegneau, MD
About this study
Official title: Prospective Monocentric Observational Study of Kidney Transplant Recipients at the CHU of Liege for the Prediction of Allograft Survival and Impact of Imaging in Clinical Decision-making.
To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, and help clinical decision-making.
To adequately predict transplant patients' individual risks of allograft loss and patients' complications, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, biopsies results, immunosuppressive regimen, allograft infections, acute kidney injuries, recipient immune profiles, protocol and per cause biopsies and imaging (PET/CT imaging).
Read more
This project aims:
- Assessed the usefulness of 18F-FDG PET/CT imaging in kidney transplantation recipients presenting with suspected acute rejection who underwent a transplant needle biopsy;
- To develop a prognostic risk score to predict kidney allograft survival;
- To evaluate the impact of corticoids withdrawal on long term outcomes (risk of rejection and impact on bone mineral density);
- Evaluate the type and the frequencies of complications in our kidney transplant population
Read the detailed description
- The detection of acute rejection in kidney transplant recipients, depends critically on assessments of serum creatinine, an insensitive measure of renal injury and the diagnosis relies on renal transplant needle biopsy which is an invasive procedure associated with a significant risk of bleeding and graft loss and is limited by sampling error and/or interobserver variability. Moreover, repeated biopsies to evaluate a renal graft's status pose challenges, including practicability and cost. Consequently, other sensitive and less invasive modalities, including gene expression profiling and omic analyses of blood and urine samples as well as in vivo imaging, are currently under investigation to reinforce our clinical armamentarium for acute rejection diagnosis. Likewise, it would be useful to non-invasively predict rejection in kidney transplant recipients with acute renal dysfunction and suspected acute rejection, thereby avoiding unnecessary transplant biopsy.
- This study aims to generate a scoring system that predicts individual patients' risk of long-term kidney allograft failure.
- Since 2007, the protocol in our institution is to withdraw the corticoids after 3 months after the protocol biopsy if no sign of rejection is demonstrated. We would like to evaluate the impact of such decision in the risk of rejection and the long-term allograft outcome in our patients. We are looking also to the impact on bone mineral density after corticoids withdrawal in those patients.
- Evaluate the type and the frequencies of complications in our kidney transplant population to adapt our daily basis clinical practice.
- Conditions
- Kidney Transplantation
- Being tested
- PET/CT imaging
- Keywords
- Allograft survival, PET/CT imaging, Corticoids withdrawal, Bone mineral Density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT imagingDiagnostic test
The PET/CT procedure was performed using cross-calibrated Philips Gemini TF Big Bore or TF 16 PET/CT systems (Philips Medical Systems, Cleveland, OH) at 201 18 minutes following intravenous injection of a mean dose of 3.2 0.2 MBq/kg of body weight of 18 F-FDG. A low-dose helical CT (5-mm slice thickness, 120-kV tube voltage, and 40-mAs tube current-time product) centered to the renal transplant was performed, followed by PET scanning with two bed positions, each lasting 240 seconds. Images were reconstructed using iterative list mode time-of-flight algorithms. Corrections for attenuation, dead time and random and scatter events were applied.
| Study group | Role | What they receive |
|---|---|---|
| Kidney recipients | Kidney recipients aged over 18 and of all sexes recruited between 2007 and 2020 from the Centre Hospitalier Universitaire de Liege, who have e-GFR follow-up and data from protocol and for cause biopsies available at 1-year post transplant. PET/CT imaging will be performed with patient's approval for protocol and per cause biopsies we performed. Data will be collected in the follow up such as clinical, biological and histological data. Receives: Diagnostic Test: PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging
Prediction model of the PET/CT imaging to predict the histological results of a biopsy.
Measured: Prediction of rejection at time of biopsies
Secondary outcomes (2)
Allograft survival probability post transplantation
Allograft survival probability calculated from clinical, histological, immunological, and functional variables assessed at the time of transplant and at the time of biopsy at 3-months post transplant.
Measured: Allograft survival probability at 1-year post transplantation
Rejection
Risk of rejection rate in patients with corticosteroids withdrawal at 3 months.
Measured: Evaluation of the risk of rejection during follow-up in patients with corticoids withdrawal at 3 months post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Jan 2007
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Bouquegneau, University of Liege
- Investigators
- FRANCOIS JOURET, PhD, Principal investigator, CHU Liege department of Nephrology-Dialysis and Transplantation, and Groupe Interdisciplinaire de Géno-protéomique Appliquée, Cardiovascular Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764124
- Sponsor's protocol ID
- Liège KO
- Status last verified
- May 2024
- First submitted
- 29 Nov 2018
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monocentric Observational Study of Kidney Transplant Recipients at the CHU of Liege for the Prediction of Allograft Survival and Impact of Imaging in Clinical Decision-making.
- ClinicalTrials.gov ID
- NCT03764124
- Acronym / sponsor ID
- Liège KO
- Conditions
- Kidney Transplantation
- Keywords
- Allograft survival, PET/CT imaging, Corticoids withdrawal, Bone mineral Density
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 4 Dec 2018 (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.
To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, and help clinical decision-making.
To adequately predict transplant patients' individual risks of allograft loss and patients' complications, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, biopsies results, immunosuppressive regimen, allograft infections, acute kidney injuries, recipient immune profiles, protocol and per cause biopsies and imaging (PET/CT imaging).
This project aims:
- Assessed the usefulness of 18F-FDG PET/CT imaging in kidney transplantation recipients presenting with suspected acute rejection who underwent a transplant needle biopsy;
- To develop a prognostic risk score to predict kidney allograft survival;
- To evaluate the impact of corticoids withdrawal on long term outcomes (risk of rejection and impact on bone mineral density);
- Evaluate the type and the frequencies of complications in our kidney transplant population
Detailed description
- The detection of acute rejection in kidney transplant recipients, depends critically on assessments of serum creatinine, an insensitive measure of renal injury and the diagnosis relies on renal transplant needle biopsy which is an invasive procedure associated with a significant risk of bleeding and graft loss and is limited by sampling error and/or interobserver variability. Moreover, repeated biopsies to evaluate a renal graft's status pose challenges, including practicability and cost. Consequently, other sensitive and less invasive modalities, including gene expression profiling and omic analyses of blood and urine samples as well as in vivo imaging, are currently under investigation to reinforce our clinical armamentarium for acute rejection diagnosis. Likewise, it would be useful to non-invasively predict rejection in kidney transplant recipients with acute renal dysfunction and suspected acute rejection, thereby avoiding unnecessary transplant biopsy.
- This study aims to generate a scoring system that predicts individual patients' risk of long-term kidney allograft failure.
- Since 2007, the protocol in our institution is to withdraw the corticoids after 3 months after the protocol biopsy if no sign of rejection is demonstrated. We would like to evaluate the impact of such decision in the risk of rejection and the long-term allograft outcome in our patients. We are looking also to the impact on bone mineral density after corticoids withdrawal in those patients.
- Evaluate the type and the frequencies of complications in our kidney transplant population to adapt our daily basis clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney recipients | – | Diagnostic Test: PET/CT imagingKidney recipients aged over 18 and of all sexes recruited between 2007 and 2020 from the Centre Hospitalier Universitaire de Liege, who have e-GFR follow-up and data from protocol and for cause biopsies available at 1-year post transplant. PET/CT imaging will be performed with patient's approval for protocol and per cause biopsies we performed. Data will be collected in the follow up such as clinical, biological and histological data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney recipients aged over 18 of all sexes recruited between 2007 and 2020 from the Centre Hospitalier Universitaire of Liege, who have e-GFR follow-up and data from protocol and for cause biopsies available at 1-year post transplant. PET/CT imaging will be performed with patient's approval for protocol and per cause biopsies we performed. Data will be collected in the follow up such as clinical, biological and histological data.
Key inclusion criteria (3 listed)
- Kidney recipient transplanted after 2007
- Kidney recipient over 18 years of age
- Clinical, biological, immunological and follow up data available
Key exclusion criteria (1 listed)
- Combined transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT imagingThe PET/CT procedure was performed using cross-calibrated Philips Gemini TF Big Bore or TF 16 PET/CT systems (Philips Medical Systems, Cleveland, OH) at 201 18 minutes following intravenous injection of a mean dose of 3.2 0.2 MBq/kg of body weight of 18 F-FDG. A low-dose helical CT (5-mm slice thickness, 120-kV tube voltage, and 40-mAs tube current-time product) centered to the renal transplant was performed, followed by PET scanning with two bed positions, each lasting 240 seconds. Images were reconstructed using iterative list mode time-of-flight algorithms. Corrections for attenuation, dead time and random and scatter events were applied. | Diagnostic test | Kidney recipients |
Primary outcome
Imaging
Time frame: Prediction of rejection at time of biopsies
Prediction model of the PET/CT imaging to predict the histological results of a biopsy.
2 secondary outcomes
Allograft survival probability post transplantation
Time frame: Allograft survival probability at 1-year post transplantation
Rejection
Time frame: Evaluation of the risk of rejection during follow-up in patients with corticoids withdrawal at 3 months post transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- 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.
Laurent Weekers, MD contact
FRANCOIS JOURET, PhD principal investigator
CHU Liege department of Nephrology-Dialysis and Transplantation, and Groupe Interdisciplinaire de Géno-protéomique Appliquée, Cardiovascular Sciences.
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 Transplantation, run by University of Liege 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 3 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine Bouquegneau, MD (0032473353321, antoine.bouquegneau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging (time frame: Prediction of rejection at time of biopsies). 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 9 May 2024.