Kidney TransplantationNCT05229939
Estimating Glomerular Filtration Rate in Kidney Transplant Recipients
An observational study of Kidney Transplantation and Glomerular Filtration Rate, run by Paris Translational Research Center for Organ Transplantation at 10 sites in 4 countries.
Trial summary
Accurate estimation of the glomerular filtration rate (GFR) is crucial for the management of kidney recipients, since it is the most predictive parameter of allograft failure that drives patient monitoring and decision-making. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation, Glomerular Filtration Rate
- How many people
- 11,412 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 1 Jan 2000to 1 Jan 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The development cohort consisted of kidney transplant recipients from 3 centres in France. The validation cohorts consisted kidney transplant recipients from 6 centers in Europe and 1 in the Unites states.
Who may be able to join
- Living or deceased donor kidney recipient transplanted between 01/01/2000 and 01/01/2021.
- Men or women over 18 years of age.
- Written informed consent at the time of transplantation for the center database.
Who cannot join
- Combined transplantation
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
France7 sites
Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon
Lyon
Department of Nephrology, Centre Hospitalier Universitaire, Montpellier
Montpellier
Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris
Paris
Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris
Paris
Kidney Transplant Department, Tenon Hospital, Assistance Publique - Hôpitaux de Paris
Paris
Nephrology, Dialysis and Renal Transplantation Department, Hôpital Nord, CHU de Saint-Etienne, Jean Monnet University, Université de Lyon
Saint-Etienne
Department of Nephrology and Organ Transplantation, CHU Rangueil
Toulouse
United States1 site
William J. von Liebig Centre for Transplantation and Clinical Regeneration, Mayo Clinic
Rochester, Minnesota
Croatia1 site
Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School of Medicine, University of Zagreb
Zagreb
About this study
Official title: Performances of Estimated Glomerular Filtration Rate Equations in Kidney Transplant Recipients
Accurate estimation of the glomerular filtration rate (GFR) is crucial for the management of kidney recipients, since it is the most predictive parameter of allograft failure that drives patient monitoring and decision-making. Standard and recent race-free GFR equations have been developed in native kidneys, but their performances in transplant kidney population remains unknown. We aimed at developing a kidney-transplant-specific GFR equation, and comparing its performance to standard GFR equations.
Read the detailed description
Historically, GFR equations, which predict the measured GFR (mGFR), were developed on patients with native kidneys and were further validated and used in kidney recipients. However, studies have shown significant heterogeneity in the performances of GFR equations when applied in kidney recipients, which may be attributed to variations and intrinsic characteristics specific to the transplant population. We thus made the hypothesis that GFR equations developed on a large, well-phenotyped kidney recipient cohort might achieve good performances in predicting mGFR.
The project therefore aims to:
- Develop new kidney-recipient-specific (KRS) GFR equations and compare their performances with the standard GFR equations
- Investigate whether the use of race increasers the performances of the new kidney-recipient-specific (KRS) GFR equations
- Evaluate the effects of the new equations on the chronic kidney disease (CKD) prevalence and GFR stage
This study will provide us with data of kidney transplant patients that may allow the development of a new KRS GFR equation.
A new KRS GFR equation that presents with increased performances, as compared to current GFR equations, will improve the GFR calculation in kidney recipients, and therefore improve clinical decisions and the long-term kidney allograft management. Decisions regarding the return to dialysis or placement on the transplant waiting list will be taken with more accuracy and therefore potentially improve the financial allocation of kidney transplantation for the society.
- Conditions
- Kidney Transplantation, Glomerular Filtration Rate
- Being tested
- No intervention
- Keywords
- Glomerular filtration rate, Kidney transplantation, Equation, Prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Kidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data
| Study group | Role | What they receive |
|---|---|---|
| Development cohort | kidney transplant recipients in 3 centres in France: Necker, Saint-Louis and Toulouse hospitals Receives: Other: No intervention | |
| Validation cohort 1 | kidney transplant recipients from Montpellier Hospital, France Receives: Other: No intervention | |
| Validation cohort 2 | kidney transplant recipients from Lyon Hospital, France Receives: Other: No intervention | |
| Validation cohort 3 | kidney transplant recipients from Tenon Hospital, France Receives: Other: No intervention | |
| Validation cohort 4 | kidney transplant recipients from Saint-Etienne Hospital, France Receives: Other: No intervention | |
| Validation cohort 5 | kidney transplant recipients from Mayo Clinic Hospital, USA Receives: Other: No intervention | |
| Validation cohort 6 | kidney transplant recipients from Bergamo hospital, Italy Receives: Other: No intervention | |
| Validation cohort 7 | kidney transplant recipients from Zagreb hospital, Croatia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured glomerular filtration rate (mGFR)
Isotopic measurements of GFR
Measured: Up to 15 years after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Jan 2000
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
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 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
- 11,412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Loupy, MD, PhD, Principal investigator, Paris Translational Research Center for Organ Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229939
- Sponsor's protocol ID
- KRSeGFR2021
- Status last verified
- Aug 2022
- First submitted
- 27 Jan 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raynaud M, Al-Awadhi S, Juric I, Divard G, Lombardi Y, Basic-Jukic N, Aubert O, Dubourg L, Masson I, Mariat C, Prie D, Pernin V, Le Quintrec M, Larson TS, Stegall MD, Bikbov B, Ruggenenti P, Mesnard L, Ibrahim HN, Nielsen MB, Matas AJ, Nankivell BJ, Benjamens S, Pol RA, Bakker SJL, Jouven X, Legendre C, Kamar N, Smith BH, Wadei HM, Durrbach A, Vincenti F, Remuzzi G, Lefaucheur C, Bentall AJ, Loupy A. Race-free estimated glomerular filtration rate equation in kidney transplant recipients: development and validation study. BMJ. 2023 May 31;381:e073654. doi: 10.1136/bmj-2022-073654.
PubMed 37257905
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performances of Estimated Glomerular Filtration Rate Equations in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT05229939
- Acronym / sponsor ID
- KRSeGFR2021
- Conditions
- Kidney Transplantation, Glomerular Filtration Rate
- Keywords
- Glomerular filtration rate, Kidney transplantation, Equation, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,412 participants (actual)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 8 Feb 2022 (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.
Accurate estimation of the glomerular filtration rate (GFR) is crucial for the management of kidney recipients, since it is the most predictive parameter of allograft failure that drives patient monitoring and decision-making. Standard and recent race-free GFR equations have been developed in native kidneys, but their performances in transplant kidney population remains unknown. We aimed at developing a kidney-transplant-specific GFR equation, and comparing its performance to standard GFR equations.
Detailed description
Historically, GFR equations, which predict the measured GFR (mGFR), were developed on patients with native kidneys and were further validated and used in kidney recipients. However, studies have shown significant heterogeneity in the performances of GFR equations when applied in kidney recipients, which may be attributed to variations and intrinsic characteristics specific to the transplant population. We thus made the hypothesis that GFR equations developed on a large, well-phenotyped kidney recipient cohort might achieve good performances in predicting mGFR.
The project therefore aims to:
- Develop new kidney-recipient-specific (KRS) GFR equations and compare their performances with the standard GFR equations
- Investigate whether the use of race increasers the performances of the new kidney-recipient-specific (KRS) GFR equations
- Evaluate the effects of the new equations on the chronic kidney disease (CKD) prevalence and GFR stage
This study will provide us with data of kidney transplant patients that may allow the development of a new KRS GFR equation.
A new KRS GFR equation that presents with increased performances, as compared to current GFR equations, will improve the GFR calculation in kidney recipients, and therefore improve clinical decisions and the long-term kidney allograft management. Decisions regarding the return to dialysis or placement on the transplant waiting list will be taken with more accuracy and therefore potentially improve the financial allocation of kidney transplantation for the society.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Development cohort | – | Other: No interventionkidney transplant recipients in 3 centres in France: Necker, Saint-Louis and Toulouse hospitals |
| Validation cohort 1 | – | Other: No interventionkidney transplant recipients from Montpellier Hospital, France |
| Validation cohort 2 | – | Other: No interventionkidney transplant recipients from Lyon Hospital, France |
| Validation cohort 3 | – | Other: No interventionkidney transplant recipients from Tenon Hospital, France |
| Validation cohort 4 | – | Other: No interventionkidney transplant recipients from Saint-Etienne Hospital, France |
| Validation cohort 5 | – | Other: No interventionkidney transplant recipients from Mayo Clinic Hospital, USA |
| Validation cohort 6 | – | Other: No interventionkidney transplant recipients from Bergamo hospital, Italy |
| Validation cohort 7 | – | Other: No interventionkidney transplant recipients from Zagreb hospital, Croatia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The development cohort consisted of kidney transplant recipients from 3 centres in France. The validation cohorts consisted kidney transplant recipients from 6 centers in Europe and 1 in the Unites states.
Key inclusion criteria (3 listed)
- Living or deceased donor kidney recipient transplanted between 01/01/2000 and 01/01/2021.
- Men or women over 18 years of age.
- Written informed consent at the time of transplantation for the center database.
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 |
|---|---|---|
| No interventionKidney recipients aged over 18 and of all sexes recruited from 2000 who have mGFR follow-up and clinical, biological, and immunological data | Other | Development cohort, Validation cohort 1, Validation cohort 2, Validation cohort 3, Validation cohort 4, Validation cohort 5, Validation cohort 6, Validation cohort 7 |
Primary outcome
Measured glomerular filtration rate (mGFR)
Time frame: Up to 15 years after kidney transplantation
Isotopic measurements of GFR
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 29 Aug 2022.
- Derived from this study: PubMed 37257905Raynaud M, Al-Awadhi S, Juric I, Divard G, Lombardi Y, Basic-Jukic N, Aubert O, Dubourg L, Masson I, Mariat C, Prie D, Pernin V, Le Quintrec M, Larson TS, Stegall MD, Bikbov B, Ruggenenti P, Mesnard L, Ibrahim HN, Nielsen MB, Matas AJ, Nankivell BJ, Benjamens S, Pol RA, Bakker SJL, Jouven X, Legendre C, Kamar N, Smith BH, Wadei HM, Durrbach A, Vincenti F, Remuzzi G, Lefaucheur C, Bentall AJ, Loupy A. Race-free estimated glomerular filtration rate equation in kidney transplant recipients: development and validation study. BMJ. 2023 May 31;381:e073654. doi: 10.1136/bmj-2022-073654.
- 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.
Alexandre Loupy, MD, PhD principal investigator
Paris Translational Research Center for Organ Transplantation
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Glomerular Filtration Rate, run by Paris Translational Research Center for Organ Transplantation at 10 sites in 4 countries.
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: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, United States, Croatia, Italy. 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?
Measured glomerular filtration rate (mGFR) (time frame: Up to 15 years after kidney transplantation). 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 NCT05229939, 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 29 Aug 2022.