Deceased Donor Kidney TransplantDDSNCT01848249
Deceased Donor Biomarkers and Recipient Outcomes
An observational study of Deceased Donor Kidney Transplant and Acute Kidney Injury, run by Yale University at 17 sites in United States.
Trial summary
Compared to chronic dialysis, kidney transplantation provides recipients with longer survival and better quality of life at a lower cost. In order to meet increasing demands for kidney allografts, kidneys from older and sicker donors are being procured. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deceased Donor Kidney Transplant, Acute Kidney Injury, Delayed Graft Function
- How many people
- 1,679 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 May 2010to Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population from which our Deceased-Donor Cohort will be selected is all potential deceased organ donors located in the regions serviced by our participating organ procurement organizations (OPOs). The recipient cohorts will be defined by the deceased donors enrolled in the study, and thus, the study population for this group is all recipients of kidneys from deceased organ donors procured in the regions serviced by our participating OPOs.
Who may be able to join
- Donor Cohort: Appropriate informed consent for research according to OPO policies
- Recipient Cohorts: Any recipient of at least one kidney from a deceased donor enrolled by our participating OPOs
Who cannot join
- Donor Cohort: Lack of adequate biospecimen quantity or quality as per protocol
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Gift of Life Michigan
Ann Arbor, Michigan, 48108
University of Maryland Medical Center
Baltimore, Maryland, 21201
Harper University Hospital
Detroit, Michigan, 48201
St. Barnabas Medical Center
Livingston, New Jersey, 07039
Yale New Haven Hospital
New Haven, Connecticut, 06510
New Jersey Sharing Network
New Providence, New Jersey, 07974
New York Organ Donor Network
New York, New York, 10001
Mount Sinai School of Medicine
New York, New York, 10029
NewYork-Presbyterian/ Columbia University Irving Medical Center
New York, New York, 10032
The New York Hospital (Cornell)
New York, New York, 10065
Montefiore Medical Center
New York, New York, 10467
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
Gift of Life Donor Program- Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
New England Organ Bank
Waltham, Massachusetts, 02451
About this study
Official title: Deceased Donor Urinary Biomarkers to Predict Kidney Transplant Outcomes
Compared to chronic dialysis, kidney transplantation provides recipients with longer survival and better quality of life at a lower cost. In order to meet increasing demands for kidney allografts, kidneys from older and sicker donors are being procured. This has led to greater discard rates of donated kidneys as well as more complications for recipients, including shorter allograft survival. Available clinical models to predict kidney allograft quality have poor prognostic ability and do not asses the degree of kidney allograft injury. However, allograft injury near the time of procurement can lead to major consequences for the transplant recipient: greater risks of delayed graft function, poor allograft function and premature loss of the transplant. Our proposal is based on the hypotheses that novel biomarkers measured in donor urine and transport media at the time of procurement can assess acute and chronic kidney injury and that distinct biomarker patterns will predict allograft survival. In collaboration with five organ procurement organizations, we will collect urine samples from consecutive deceased donors and samples of transport solution for every pumped kidney. We will measure markers of injury, repair, inflammation and fibrosis. We will determine mortality and allograft survival in all patients by linkage to the United Network for Organ Sharing (UNOS) database (Overall Cohort). Additionally, we will perform a detailed chart review of a subset of recipients (detailed cohort) and will also examine associations between biomarkers and longitudinal graft function over five years after transplant. Early, non-invasive and rapid assessment of donor kidney injury could drive better allocation decisions and potentially reduce the rates of post-transplant complications. Further, these new tools could provide a platform for clinical trials of therapies for allografts and kidney transplant recipients aimed at ameliorating allograft injury.
Read the detailed description
Our study has several key processes that we have developed and tested to address our scientific aims:
- Enrollment We will collect urine samples from approximately 1600 deceased donors and approximately 600 perfusate samples from machine-pumped kidneys from participating organ procurement organizations (OPOs). We estimate that our final donor group will be comprised of 55% standard criteria donors, 25% expanded-criteria donors and 10% donors after cardiac death. Approximately, 20% of the kidneys will be discarded.
- Donor Data Donor variables come from two sources: the United Network for Organ Sharing (UNOS) database and detailed data abstraction from each OPO. The UNOS database provides data on all donors with demographics and other important clinical characteristics. The additional data collected by the OPO staff captures granular information on events surrounding donor death, which are not included in the UNOS database. These data will be available on all enrolled donors and include variables such as serial serum creatinine, nadir blood pressures, medication and vasopressor use, and machine pump parameters.
- Overall Recipient Cohort Over 2000 recipients will have received kidneys from the deceased donors in our study. The Overall Cohort will comprise all of these recipients General demographic and clinical characteristics about recipients in the Overall Cohort will come from the UNOS database. For the Overall Recipient Cohort, we will ascertain delayed graft function (DGF) through center reports to UNOS. We will ascertain allograft failure through center reports to UNOS and new episodes of wait-listing and re-transplant collected by UNOS, Recipient mortality will be ascertained through the center reports to UNOS/SRTR and through the Social Security Death Master File.
- Detailed Recipient Cohort A subset of over 1100 recipients of the Overall Cohort who had transplantation at any of our collaborating transplant centers will comprise this cohort. For the Detailed Subcohort, on-site coordinators will perform manual chart review and abstract more extensive data about each recipient including dialysis indications post-transplant, comorbidities, and specific doses of immunosuppression. For the Detailed Subcohort, we will also collect data on clinical events for up to five years after transplantation, including acute rejection and estimated glomerular filtration rate at the time of transplantation and at months 1, 3, 6, 12, 18, 24, 30, 36, 48 and 60 months after transplant.
- Novel biomarkers will be measured in urine and perfusate
- Conditions
- Deceased Donor Kidney Transplant, Acute Kidney Injury, Delayed Graft Function, End Stage Renal Disease, Graft Failure
- Keywords
- deceased donors, kidney donor, transplant recipients, kidney transplant, delayed graft function, biomarkers, end stage renal disease, graft failure
- Medical subject headings
- Acute Kidney Injury, Delayed Graft Function, Kidney Failure, Chronic
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 |
|---|---|---|
| Deceased-Donor Cohort | We will collect urine samples from approximately 1600 deceased donors and approximately 600 perfusate samples from machine-pumped kidneys from participating organ procurement organizations (OPOs). | |
| Recipient Cohort (Overall and Detailed) | No samples will be collected from the recipients. Only clinical data and outcomes will be collected from the recipients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Graft Function
Receipt of dialysis within the first seven days post renal transplant
Measured: Assessed within first week of receiving renal transplant
Death-Censored Graft Failure (Overall Cohort)
Requirement of chronic dialysis or retransplantation after renal transplant.
Measured: median of 4 years of follow-up
Secondary outcomes (1)
Graft Function (detailed cohort)
Serum creatinine and estimated glomerular filtration rate at specified time points over a five year period.
Measured: median of 4 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study start1 May 2010
- Primary completionDec 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Deceased Donor Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 1,679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Chirag R Parikh, MD PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848249
- Sponsor's protocol ID
- 1206010465
- Other IDs
- R01DK093770-01A1
- Acronym
- DDS
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2013
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hall IE, Bhangoo RS, Reese PP, Doshi MD, Weng FL, Hong K, Lin H, Han G, Hasz RD, Goldstein MJ, Schroppel B, Parikh CR. Glutathione S-transferase iso-enzymes in perfusate from pumped kidneys are associated with delayed graft function. Am J Transplant. 2014 Apr;14(4):886-96. doi: 10.1111/ajt.12635. Epub 2014 Feb 24.
PubMed 24612768Hall IE, Reese PP, Weng FL, Schroppel B, Doshi MD, Hasz RD, Reitsma W, Goldstein MJ, Hong K, Parikh CR. Preimplant histologic acute tubular necrosis and allograft outcomes. Clin J Am Soc Nephrol. 2014 Mar;9(3):573-82. doi: 10.2215/CJN.08270813. Epub 2014 Feb 20.
PubMed 24558049Liu C, Hall IE, Mansour S, Thiessen Philbrook HR, Jia Y, Parikh CR. Association of Deceased Donor Acute Kidney Injury With Recipient Graft Survival. JAMA Netw Open. 2020 Jan 3;3(1):e1918634. doi: 10.1001/jamanetworkopen.2019.18634.
PubMed 31913491Puthumana J, Hall IE, Reese PP, Schroppel B, Weng FL, Thiessen-Philbrook H, Doshi MD, Rao V, Lee CG, Elias JA, Cantley LG, Parikh CR. YKL-40 Associates with Renal Recovery in Deceased Donor Kidney Transplantation. J Am Soc Nephrol. 2017 Feb;28(2):661-670. doi: 10.1681/ASN.2016010091. Epub 2016 Jul 22.
PubMed 27451287Yaffe HC, von Ahrens D, Urioste A, Mas VR, Akalin E. Impact of Deceased-donor Acute Kidney Injury on Kidney Transplantation. Transplantation. 2024 Jun 1;108(6):1283-1295. doi: 10.1097/TP.0000000000004848. Epub 2023 Nov 22.
PubMed 37990359
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deceased Donor Urinary Biomarkers to Predict Kidney Transplant Outcomes
- ClinicalTrials.gov ID
- NCT01848249
- Acronym / sponsor ID
- DDS / 1206010465
- Conditions
- Deceased Donor Kidney Transplant, Acute Kidney Injury, Delayed Graft Function, End Stage Renal Disease, Graft Failure
- Keywords
- deceased donors, kidney donor, transplant recipients, kidney transplant, delayed graft function, biomarkers, end stage renal disease, graft failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,679 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Johns Hopkins University
- Study start
- 1 May 2010
- Primary completion
- Dec 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 7 May 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.
Compared to chronic dialysis, kidney transplantation provides recipients with longer survival and better quality of life at a lower cost. In order to meet increasing demands for kidney allografts, kidneys from older and sicker donors are being procured. This has led to greater discard rates of donated kidneys as well as more complications for recipients, including shorter allograft survival. Available clinical models to predict kidney allograft quality have poor prognostic ability and do not asses the degree of kidney allograft injury. However, allograft injury near the time of procurement can lead to major consequences for the transplant recipient: greater risks of delayed graft function, poor allograft function and premature loss of the transplant. Our proposal is based on the hypotheses that novel biomarkers measured in donor urine and transport media at the time of procurement can assess acute and chronic kidney injury and that distinct biomarker patterns will predict allograft survival. In collaboration with five organ procurement organizations, we will collect urine samples from consecutive deceased donors and samples of transport solution for every pumped kidney. We will measure markers of injury, repair, inflammation and fibrosis. We will determine mortality and allograft survival in all patients by linkage to the United Network for Organ Sharing (UNOS) database (Overall Cohort). Additionally, we will perform a detailed chart review of a subset of recipients (detailed cohort) and will also examine associations between biomarkers and longitudinal graft function over five years after transplant. Early, non-invasive and rapid assessment of donor kidney injury could drive better allocation decisions and potentially reduce the rates of post-transplant complications. Further, these new tools could provide a platform for clinical trials of therapies for allografts and kidney transplant recipients aimed at ameliorating allograft injury.
Detailed description
Our study has several key processes that we have developed and tested to address our scientific aims:
- Enrollment We will collect urine samples from approximately 1600 deceased donors and approximately 600 perfusate samples from machine-pumped kidneys from participating organ procurement organizations (OPOs). We estimate that our final donor group will be comprised of 55% standard criteria donors, 25% expanded-criteria donors and 10% donors after cardiac death. Approximately, 20% of the kidneys will be discarded.
- Donor Data Donor variables come from two sources: the United Network for Organ Sharing (UNOS) database and detailed data abstraction from each OPO. The UNOS database provides data on all donors with demographics and other important clinical characteristics. The additional data collected by the OPO staff captures granular information on events surrounding donor death, which are not included in the UNOS database. These data will be available on all enrolled donors and include variables such as serial serum creatinine, nadir blood pressures, medication and vasopressor use, and machine pump parameters.
- Overall Recipient Cohort Over 2000 recipients will have received kidneys from the deceased donors in our study. The Overall Cohort will comprise all of these recipients General demographic and clinical characteristics about recipients in the Overall Cohort will come from the UNOS database. For the Overall Recipient Cohort, we will ascertain delayed graft function (DGF) through center reports to UNOS. We will ascertain allograft failure through center reports to UNOS and new episodes of wait-listing and re-transplant collected by UNOS, Recipient mortality will be ascertained through the center reports to UNOS/SRTR and through the Social Security Death Master File.
- Detailed Recipient Cohort A subset of over 1100 recipients of the Overall Cohort who had transplantation at any of our collaborating transplant centers will comprise this cohort. For the Detailed Subcohort, on-site coordinators will perform manual chart review and abstract more extensive data about each recipient including dialysis indications post-transplant, comorbidities, and specific doses of immunosuppression. For the Detailed Subcohort, we will also collect data on clinical events for up to five years after transplantation, including acute rejection and estimated glomerular filtration rate at the time of transplantation and at months 1, 3, 6, 12, 18, 24, 30, 36, 48 and 60 months after transplant.
- Novel biomarkers will be measured in urine and perfusate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deceased-Donor Cohort | – | –We will collect urine samples from approximately 1600 deceased donors and approximately 600 perfusate samples from machine-pumped kidneys from participating organ procurement organizations (OPOs). |
| Recipient Cohort (Overall and Detailed) | – | –No samples will be collected from the recipients. Only clinical data and outcomes will be collected from the recipients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population from which our Deceased-Donor Cohort will be selected is all potential deceased organ donors located in the regions serviced by our participating organ procurement organizations (OPOs). The recipient cohorts will be defined by the deceased donors enrolled in the study, and thus, the study population for this group is all recipients of kidneys from deceased organ donors procured in the regions serviced by our participating OPOs.
Key inclusion criteria (2 listed)
- Donor Cohort: Appropriate informed consent for research according to OPO policies
- Recipient Cohorts: Any recipient of at least one kidney from a deceased donor enrolled by our participating OPOs
Key exclusion criteria (1 listed)
- Donor Cohort: Lack of adequate biospecimen quantity or quality as per protocol
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
Delayed Graft Function
Time frame: Assessed within first week of receiving renal transplant
Receipt of dialysis within the first seven days post renal transplant
Death-Censored Graft Failure (Overall Cohort)
Time frame: median of 4 years of follow-up
Requirement of chronic dialysis or retransplantation after renal transplant.
1 secondary outcome
Graft Function (detailed cohort)
Time frame: median of 4 years of follow-up
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 9 Apr 2020.
- Results publication: PubMed 24612768Hall IE, Bhangoo RS, Reese PP, Doshi MD, Weng FL, Hong K, Lin H, Han G, Hasz RD, Goldstein MJ, Schroppel B, Parikh CR. Glutathione S-transferase iso-enzymes in perfusate from pumped kidneys are associated with delayed graft function. Am J Transplant. 2014 Apr;14(4):886-96. doi: 10.1111/ajt.12635. Epub 2014 Feb 24.
- Results publication: PubMed 24558049Hall IE, Reese PP, Weng FL, Schroppel B, Doshi MD, Hasz RD, Reitsma W, Goldstein MJ, Hong K, Parikh CR. Preimplant histologic acute tubular necrosis and allograft outcomes. Clin J Am Soc Nephrol. 2014 Mar;9(3):573-82. doi: 10.2215/CJN.08270813. Epub 2014 Feb 20.
- Results publication: PubMed 31913491Liu C, Hall IE, Mansour S, Thiessen Philbrook HR, Jia Y, Parikh CR. Association of Deceased Donor Acute Kidney Injury With Recipient Graft Survival. JAMA Netw Open. 2020 Jan 3;3(1):e1918634. doi: 10.1001/jamanetworkopen.2019.18634.
- Results publication: PubMed 27451287Puthumana J, Hall IE, Reese PP, Schroppel B, Weng FL, Thiessen-Philbrook H, Doshi MD, Rao V, Lee CG, Elias JA, Cantley LG, Parikh CR. YKL-40 Associates with Renal Recovery in Deceased Donor Kidney Transplantation. J Am Soc Nephrol. 2017 Feb;28(2):661-670. doi: 10.1681/ASN.2016010091. Epub 2016 Jul 22.
- Derived from this study: PubMed 37990359Yaffe HC, von Ahrens D, Urioste A, Mas VR, Akalin E. Impact of Deceased-donor Acute Kidney Injury on Kidney Transplantation. Transplantation. 2024 Jun 1;108(6):1283-1295. doi: 10.1097/TP.0000000000004848. Epub 2023 Nov 22.
- Pubmed Link for Deceased Donor StudyLink provided by the sponsor.
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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.
Chirag R Parikh, MD PhD principal investigator
Yale University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deceased Donor Kidney Transplant and Acute Kidney Injury, run by Yale University at 17 sites in United States.
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 2 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 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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?
Delayed Graft Function (time frame: Assessed within first week of receiving renal transplant). The study lists 2 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 NCT01848249, which also lists 5 linked publications.
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 Apr 2020.