Kidney Transplant FailureTRAJAKTNCT04226859
Trajectories of Glomerular Filtration Rate and Progression to End Stage Renal Disease After Kidney Transplantation
An observational study of Kidney Transplant Failure and Kidney Function Issue, run by Paris Translational Research Center for Organ Transplantation at 15 sites in 4 countries.
Trial summary
The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure, Kidney Function Issue
- How many people
- 14,000 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Jan 2000to Jun 2020
- 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
- Adult, Older adult
Study population: Kidney recipients aged over 18 and of all sexes recruited from 2000 in European and North American centers, who have eGFR repeated measurements, data from protocol and for cause biopsies, as well as immunological, clinical, functional parameters and survival data for allograft and patient survival assessment. Additional kidney recipients from RCTs with longitudinal data including baseline and follow-up clinical, functional, immunological and histological data.
Who may be able to join
- Kidney recipients transplanted after 2000
- Kidney recipients over 18 years of age
- Kidney recipients with at least two eGFR measurements after transplantation
Who cannot join
- Combined transplantation
Trial locations and contacts
15 sites in 4 countries.
Alexandre Loupy, Professor contact
15 sites in 4 countries
France8 sites, 8 recruiting
- Enrolling by invitation
Department of Nephrology, Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
- Enrolling by invitation
Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy
Nancy, 54035
- Enrolling by invitation
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
- Recruiting
Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris
Paris, 75010
Carmen Lefaucheur, MD
- Recruiting
Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris
Paris, 75015
Alexandre Loupy, Professor, +33612491082, alexandre.loupy@inserm.fr
- Enrolling by invitation
Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch
Suresnes, 92150
- Enrolling by invitation
Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil
Toulouse, 31059
- Enrolling by invitation
Bretonneau Hospital, Nephrology and Immunology Department
Tours, 37000
United States5 sites, 5 recruiting
- Enrolling by invitation
Department of Surgery, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
- Enrolling by invitation
Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center
Los Angeles, California, 90048
- Enrolling by invitation
Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program
New York, New York, 10467
- Enrolling by invitation
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 980663
- Enrolling by invitation
William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic
Rochester, Minnesota, 55905
Belgium1 site, 1 recruiting
- Enrolling by invitation
Department of Nephrology and Renal Transplantation, University Hospitals Leuven
Leuven, 3000
Croatia1 site, 1 recruiting
- Enrolling by invitation
Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb
Zagreb, 10000
About this study
Official title: Multicenter International Observational Study to Identify eGFR Trajectories and Their Determinants, and to Build a Multidimensional Prediction System to Predict the Probabilities of Belonging to eGFR Trajectories
The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. In particular, the National Kidney Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several studies, the eGFR slope or change has been found to be strongly associated with end stage renal disease (ESRD).
However, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described.
Read more
An unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease.
Therefore, this study aims:
- To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models;
- To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions;
- To investigate the associations of the eGFR trajectories with the progression to ESRD and death.
Based on the results, the investigators will provide an easily accessible tool to calculate personalized probabilities of belonging to eGFR trajectories after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.
Read the detailed description
Background
Chronic kidney disease (CKD) now affects 850 million individuals worldwide, exceeding the global prevalence of diabetes, cancer and HIV/AIDS. In addition, end-stage renal disease affects 7.4 million individuals and mortality rate for individuals burdened by kidney disease is now estimated at 5 to 10 million individuals each year. Therefore, developing better diagnostic and treatment approaches for the kidney disease epidemic is a global priority, as leading professional societies and health agencies have emphasized (the US Food \& Drug Administration, the National Kidney Foundation, the European Medicines Agency, the European Society of Organ Transplantation, the American Society for Transplantation and the American Society of Transplant Surgeons).
However, current approaches for investigating the relationship between eGFR course and outcomes such as ESRD and mortality have been limited by registries with an overall lack on granular data, including infrequent eGFR measurements for a single patient and convenience clinical samples. An unsupervised longitudinal approach to determine patient eGFR evolution may bring an original perspective to the traditional clinical interpretation of kidney function based on limited eGFR measurements, short-term follow-up, and standard statistical approach.
Main Outcome(s) and Measure(s)
- eGFR trajectories
- Determinants of eGFR trajectories
- Associations of eGFR trajectories with ESRD and death
- Prediction system that will provide the personalized probabilities of belonging to eGFR trajectories
- Conditions
- Kidney Transplant Failure, Kidney Function Issue
- Being tested
- No intervention
- Keywords
- Kidney Transplantation, Graft Survival, Glomerular Filtration Rate, Trajectories
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 in European and North American centers, who have eGFR follow-up and data from protocol and for cause biopsies available for allograft survival assessment; Randomized controlled trials conducted over the past 20 years with available data on protocol biopsy within the first year and follow up clinical, biological and histological data.
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR trajectories
eGFR trajectories probabilities, calculated from a prediction system (based on clinical, histological, immunological, and functional factors) assessed at 1-year post transplantation.
Measured: Up to 10 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 posted13 Jan 2020
- Study startJan 2000
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant FailureStudies 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
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Loupy, Professor, Principal investigator, Paris Translational Research Center for Organ Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226859
- Sponsor's protocol ID
- TRAJAKT
- Acronym
- TRAJAKT
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter International Observational Study to Identify eGFR Trajectories and Their Determinants, and to Build a Multidimensional Prediction System to Predict the Probabilities of Belonging to eGFR Trajectories
- ClinicalTrials.gov ID
- NCT04226859
- Acronym / sponsor ID
- TRAJAKT / TRAJAKT
- Conditions
- Kidney Transplant Failure, Kidney Function Issue
- Keywords
- Kidney Transplantation, Graft Survival, Glomerular Filtration Rate, Trajectories
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- Jan 2000 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 13 Jan 2020 (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.
The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. In particular, the National Kidney Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several studies, the eGFR slope or change has been found to be strongly associated with end stage renal disease (ESRD).
However, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described.
An unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease.
Therefore, this study aims:
- To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models;
- To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions;
- To investigate the associations of the eGFR trajectories with the progression to ESRD and death.
Based on the results, the investigators will provide an easily accessible tool to calculate personalized probabilities of belonging to eGFR trajectories after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.
Detailed description
Background
Chronic kidney disease (CKD) now affects 850 million individuals worldwide, exceeding the global prevalence of diabetes, cancer and HIV/AIDS. In addition, end-stage renal disease affects 7.4 million individuals and mortality rate for individuals burdened by kidney disease is now estimated at 5 to 10 million individuals each year. Therefore, developing better diagnostic and treatment approaches for the kidney disease epidemic is a global priority, as leading professional societies and health agencies have emphasized (the US Food \& Drug Administration, the National Kidney Foundation, the European Medicines Agency, the European Society of Organ Transplantation, the American Society for Transplantation and the American Society of Transplant Surgeons).
However, current approaches for investigating the relationship between eGFR course and outcomes such as ESRD and mortality have been limited by registries with an overall lack on granular data, including infrequent eGFR measurements for a single patient and convenience clinical samples. An unsupervised longitudinal approach to determine patient eGFR evolution may bring an original perspective to the traditional clinical interpretation of kidney function based on limited eGFR measurements, short-term follow-up, and standard statistical approach.
Main Outcome(s) and Measure(s)
- eGFR trajectories
- Determinants of eGFR trajectories
- Associations of eGFR trajectories with ESRD and death
- Prediction system that will provide the personalized probabilities of belonging to eGFR trajectories
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Kidney recipients aged over 18 and of all sexes recruited from 2000 in European and North American centers, who have eGFR repeated measurements, data from protocol and for cause biopsies, as well as immunological, clinical, functional parameters and survival data for allograft and patient survival assessment. Additional kidney recipients from RCTs with longitudinal data including baseline and follow-up clinical, functional, immunological and histological data.
Key inclusion criteria (3 listed)
- Kidney recipients transplanted after 2000
- Kidney recipients over 18 years of age
- Kidney recipients with at least two eGFR measurements after transplantation
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 in European and North American centers, who have eGFR follow-up and data from protocol and for cause biopsies available for allograft survival assessment; Randomized controlled trials conducted over the past 20 years with available data on protocol biopsy within the first year and follow up clinical, biological and histological data. | Other | – |
Primary outcome
eGFR trajectories
Time frame: Up to 10 years after kidney transplantation
eGFR trajectories probabilities, calculated from a prediction system (based on clinical, histological, immunological, and functional factors) assessed at 1-year post transplantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Paris Transplant Group WebsiteLink provided by the sponsor.
- 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, Professor contact
Alexandre Loupy, Professor principal investigator
Paris Translational Research Center for Organ Transplantation
15 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 Transplant Failure and Kidney Function Issue, run by Paris Translational Research Center for Organ Transplantation at 15 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: status not confirmed, as of the sponsor's last update on 18 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 15 sites in France, United States, Belgium, Croatia. 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 Alexandre Loupy, Professor (alexandre.loupy@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR trajectories (time frame: Up to 10 years after kidney transplantation). 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 18 Jan 2020.