Kidney Transplant FailureDYNAKTNCT04258891
Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation
An observational study of Kidney Transplant Failure, run by Paris Translational Research Center for Organ Transplantation at 18 sites in 7 countries.
Trial summary
The incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure
- How many people
- 14,000 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 1 Jan 2004to 30 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 2004 in European and North American centers, who have estimated glomerular filtration rate and proteinuria 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 2004
- Kidney recipients over 18 years of age
- Kidney recipients with at least two estimated glomerular filtration rate and proteinuria measurements after transplantation
Who cannot join
- Combined transplantation
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
France7 sites
Department of Nephrology, Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy
Nancy, 54035
Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris
Paris, 75010
Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris
Paris, 75015
Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch
Suresnes, 92150
Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil
Toulouse, 31059
Bretonneau Hospital, Nephrology and Immunology Department
Tours, 37000
United States5 sites
Department of Surgery, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Division of Transplantation, Department of Surgery, Feinberg School of Medicine, Northwestern University
Chicago, Illinois, 60611
Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center
Los Angeles, California, 90048
Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program
New York, New York, 10467
William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic
Rochester, Minnesota, 55905
Brazil2 sites
Universidade Federal de São Paulo, Hospital do Rim, Escola Paulista de Medicina
São Paulo, 04038-002
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Renal Transplantation Service
São Paulo, 05403-000
Argentina1 site
Unidad de Trasplante Renopáncreas, Centro de Educación Médica e Investigaciones Clínicas
Buenos Aires, 4102
Croatia1 site
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: Development and Validation of a Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation
The incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Although some ESRD prediction models have been derived in the past years, none of these models are dynamic: they do not integrate the repeated measurements recorded throughout individuals' follow-up.
As highlighted in several studies, kidney function repeated measurements (i.e., trajectories) are highly associated with graft survival after kidney transplantation. The investigators made the hypothesis that these trajectories may bring relevant information in the context of graft survival risk prediction model. Hence, combining these trajectories with standard graft survival risk factors may enhance prediction performance. This could permit to derive a robust tool that could be updated over time by continuously capturing patient' personal evolution.
Read the detailed description
850 million individuals suffer from chronic kidney disease (CKD), while diabetes, cancer, and HIV/AIDS affect 422, 42, and 37 million individuals, respectively. End stage renal disease (ESRD) hence places a heavy burden on health systems worldwide. Linked to that, the kidney-disease-associated mortality rate worldwide has risen over the past decade, now causing the death of 5 to 10 million individuals every year.
In kidney transplantation, numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, sometimes leading to graft failure. Current approaches for investigating the relationship between these factors and graft failure have been limited by standard statistical approaches and by registries with an overall lack on granular data, including infrequent kidney function measurements for a single patient and convenience clinical samples. Identifying the determinants of graft failure with a dynamic approach may bring an original perspective to the traditional graft survival risk prediction model that are impeded by their reliance on low-granularity datasets, cross-sectional parameters, and limited follow-up.
- Conditions
- Kidney Transplant Failure
- Being tested
- No intervention
- Keywords
- Kidney Transplantation, Graft survival, Kidney function, Prediction, Dynamic
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 2004 in European, North American and South American centers, who have estimated glomerular filtration rate and proteinuria follow-up and data from protocol and for cause biopsies 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.
Allograft survival probability
Allograft survival probability, calculated from a dynamic prediction system, based on clinical, histological, immunological and estimated glomerular filtration rate and proteinuria repeated measurements, assessed at the time of risk evaluation and that can be updated thereafter.
Measured: Up to 10 years after kidney transplantation
Secondary outcomes (1)
Added prognostic value
Added prognostic value of the dynamic prediction system over standard of care monitoring of kidney transplant recipients based on single value of estimated glomerular filtration rate and proteinuria
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 posted6 Feb 2020
- Study start1 Jan 2004
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
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 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
- NCT04258891
- Sponsor's protocol ID
- DYNAKT
- Acronym
- DYNAKT
- Status last verified
- Sep 2020
- First submitted
- 4 Feb 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raynaud M, Aubert O, Divard G, Reese PP, Kamar N, Yoo D, Chin CS, Bailly E, Buchler M, Ladriere M, Le Quintrec M, Delahousse M, Juric I, Basic-Jukic N, Crespo M, Silva HT Jr, Linhares K, Ribeiro de Castro MC, Soler Pujol G, Empana JP, Ulloa C, Akalin E, Bohmig G, Huang E, Stegall MD, Bentall AJ, Montgomery RA, Jordan SC, Oberbauer R, Segev DL, Friedewald JJ, Jouven X, Legendre C, Lefaucheur C, Loupy A. Dynamic prediction of renal survival among deeply phenotyped kidney transplant recipients using artificial intelligence: an observational, international, multicohort study. Lancet Digit Health. 2021 Dec;3(12):e795-e805. doi: 10.1016/S2589-7500(21)00209-0. Epub 2021 Oct 28.
PubMed 34756569
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04258891
- Acronym / sponsor ID
- DYNAKT / DYNAKT
- Conditions
- Kidney Transplant Failure
- Keywords
- Kidney Transplantation, Graft survival, Kidney function, Prediction, Dynamic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Feb 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 incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Although some ESRD prediction models have been derived in the past years, none of these models are dynamic: they do not integrate the repeated measurements recorded throughout individuals' follow-up.
As highlighted in several studies, kidney function repeated measurements (i.e., trajectories) are highly associated with graft survival after kidney transplantation. The investigators made the hypothesis that these trajectories may bring relevant information in the context of graft survival risk prediction model. Hence, combining these trajectories with standard graft survival risk factors may enhance prediction performance. This could permit to derive a robust tool that could be updated over time by continuously capturing patient' personal evolution.
Detailed description
850 million individuals suffer from chronic kidney disease (CKD), while diabetes, cancer, and HIV/AIDS affect 422, 42, and 37 million individuals, respectively. End stage renal disease (ESRD) hence places a heavy burden on health systems worldwide. Linked to that, the kidney-disease-associated mortality rate worldwide has risen over the past decade, now causing the death of 5 to 10 million individuals every year.
In kidney transplantation, numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, sometimes leading to graft failure. Current approaches for investigating the relationship between these factors and graft failure have been limited by standard statistical approaches and by registries with an overall lack on granular data, including infrequent kidney function measurements for a single patient and convenience clinical samples. Identifying the determinants of graft failure with a dynamic approach may bring an original perspective to the traditional graft survival risk prediction model that are impeded by their reliance on low-granularity datasets, cross-sectional parameters, and limited follow-up.
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 2004 in European and North American centers, who have estimated glomerular filtration rate and proteinuria 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 2004
- Kidney recipients over 18 years of age
- Kidney recipients with at least two estimated glomerular filtration rate and proteinuria 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 2004 in European, North American and South American centers, who have estimated glomerular filtration rate and proteinuria follow-up and data from protocol and for cause biopsies 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
Allograft survival probability
Time frame: Up to 10 years after kidney transplantation
Allograft survival probability, calculated from a dynamic prediction system, based on clinical, histological, immunological and estimated glomerular filtration rate and proteinuria repeated measurements, assessed at the time of risk evaluation and that can be updated thereafter.
1 secondary outcome
Added prognostic value
Time frame: Up to 10 years after kidney 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 16 Sep 2020.
- Derived from this study: PubMed 34756569Raynaud M, Aubert O, Divard G, Reese PP, Kamar N, Yoo D, Chin CS, Bailly E, Buchler M, Ladriere M, Le Quintrec M, Delahousse M, Juric I, Basic-Jukic N, Crespo M, Silva HT Jr, Linhares K, Ribeiro de Castro MC, Soler Pujol G, Empana JP, Ulloa C, Akalin E, Bohmig G, Huang E, Stegall MD, Bentall AJ, Montgomery RA, Jordan SC, Oberbauer R, Segev DL, Friedewald JJ, Jouven X, Legendre C, Lefaucheur C, Loupy A. Dynamic prediction of renal survival among deeply phenotyped kidney transplant recipients using artificial intelligence: an observational, international, multicohort study. Lancet Digit Health. 2021 Dec;3(12):e795-e805. doi: 10.1016/S2589-7500(21)00209-0. Epub 2021 Oct 28.
- 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 principal investigator
Paris Translational Research Center for Organ Transplantation
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure, run by Paris Translational Research Center for Organ Transplantation at 18 sites in 7 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, United States, Brazil, Argentina, Chile and 2 more countries. 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?
Allograft survival probability (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?
On the ClinicalTrials.gov record for NCT04258891, 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 16 Sep 2020.