Complication of TransplantNCT02514733
Association of Donor Age With Recipient Outcomes in Kidney Transplant
An observational study of Complication of Transplant, run by Northwestern University at 1 site in United States.
Trial summary
This is a single center study that seeks to study the impact of donor age on recipient outcomes in older kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Complication of Transplant
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Apr 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All older kidney transplant recipients, age >=60 at transplant who underwent the procedure at Northwestern University during specified time frame ( see below)
Who may be able to join
- All adult kidney transplant recipients
- Recipient age > 60 years at the time of transplant
- Transplant was done between January 1, 2013 and December 31, 2014
Who cannot join
- Recipients of more than one kidney transplant
- Recipients of multi-organ transplants
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Comprehensive Transplant Center
Chicago, Illinois, 60611
About this study
This is a single center study that seeks to study the impact of donor age on recipient outcomes in older kidney transplant recipients.
Read the detailed description
Over the years use of older kidney allografts has increased in an attempt to bridge the gap between demand and supply of organs. Simultaneously there has been in increase in the number of elderly renal transplant recipients. Numerous factors, both graft and host related, can impact recipient outcomes. The aim of this study is to evaluate the impact of donor age on recipient outcomes, based on the hypothesis is that elderly recipients who receive an older allograft have poorer outcomes that those who receive a younger allograft.
Study subjects will be recruited from the cohort of patients who received a kidney transplant at Northwestern Memorial Hospital.
The transplant clinical database and electronic medical record (OTTR) used in the Comprehensive Transplant Center at Northwestern University will be scanned to screen for kidney transplant recipients who fit the inclusion and exclusion criteria. Potential subjects will then be consented to participate in the study (see attached consent form), and subject participation will be documented in OTTR.
The sample size for the study is 80 subjects, who will be divided into 2 groups based on recipient and donor age. All demographic and clinical data will be collected for the donor and recipients at time of transplant. Follow up clinical data, including but not limited to recipient survival and graft failure will be collected and analyzed for the recipients. Subject confidentiality will be strictly maintained. All subject data will be stored on a secure server and only shared between members of the research team. The investigators plan to publish the results in a peer reviewed journal.
- Conditions
- Complication of Transplant
- Keywords
- kidney, transplant
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 |
|---|---|---|
| Young donor | Kidney transplant recipient > 60 years of age who received organ from donor <=40 years of age | |
| Old donor | Kidney transplant recipient >= 60 years of age who received organ from donor >=50 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft failure
Graft failure in this study is defined as need for chronic dialysis or re-transplant.
Measured: 2 years post transplant
Secondary outcomes (1)
Recipient survival
Measured: 2 years post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startMay 2016
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: Due to a lack of laboratory resources, the study was abandoned.
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 Complication of TransplantStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Gallon, Northwestern University
- Investigators
- Lorenzo Gallon, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514733
- Sponsor's protocol ID
- STU00200153
- Status last verified
- Sep 2018
- First submitted
- 28 Jul 2015
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Knoll GA. Kidney transplantation in the older adult. Am J Kidney Dis. 2013 May;61(5):790-7. doi: 10.1053/j.ajkd.2012.08.049. Epub 2012 Dec 20.
PubMed 23261121
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Donor Age With Recipient Outcomes in Kidney Transplant
- ClinicalTrials.gov ID
- NCT02514733
- Acronym / sponsor ID
- STU00200153
- Conditions
- Complication of Transplant
- Keywords
- kidney, transplant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to a lack of laboratory resources, the study was abandoned.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 4 Aug 2015 (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.
This is a single center study that seeks to study the impact of donor age on recipient outcomes in older kidney transplant recipients.
Detailed description
Over the years use of older kidney allografts has increased in an attempt to bridge the gap between demand and supply of organs. Simultaneously there has been in increase in the number of elderly renal transplant recipients. Numerous factors, both graft and host related, can impact recipient outcomes. The aim of this study is to evaluate the impact of donor age on recipient outcomes, based on the hypothesis is that elderly recipients who receive an older allograft have poorer outcomes that those who receive a younger allograft.
Study subjects will be recruited from the cohort of patients who received a kidney transplant at Northwestern Memorial Hospital.
The transplant clinical database and electronic medical record (OTTR) used in the Comprehensive Transplant Center at Northwestern University will be scanned to screen for kidney transplant recipients who fit the inclusion and exclusion criteria. Potential subjects will then be consented to participate in the study (see attached consent form), and subject participation will be documented in OTTR.
The sample size for the study is 80 subjects, who will be divided into 2 groups based on recipient and donor age. All demographic and clinical data will be collected for the donor and recipients at time of transplant. Follow up clinical data, including but not limited to recipient survival and graft failure will be collected and analyzed for the recipients. Subject confidentiality will be strictly maintained. All subject data will be stored on a secure server and only shared between members of the research team. The investigators plan to publish the results in a peer reviewed journal.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young donor | – | –Kidney transplant recipient > 60 years of age who received organ from donor <=40 years of age |
| Old donor | – | –Kidney transplant recipient >= 60 years of age who received organ from donor >=50 years of age |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All older kidney transplant recipients, age >=60 at transplant who underwent the procedure at Northwestern University during specified time frame ( see below)
Key inclusion criteria (3 listed)
- All adult kidney transplant recipients
- Recipient age > 60 years at the time of transplant
- Transplant was done between January 1, 2013 and December 31, 2014
Key exclusion criteria (2 listed)
- Recipients of more than one kidney transplant
- Recipients of multi-organ transplants
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
Graft failure
Time frame: 2 years post transplant
Graft failure in this study is defined as need for chronic dialysis or re-transplant.
1 secondary outcome
Recipient survival
Time frame: 2 years post transplant
Results and safety
The study was stopped early (reason given: Due to a lack of laboratory resources, the study was abandoned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Background: PubMed 23261121Knoll GA. Kidney transplantation in the older adult. Am J Kidney Dis. 2013 May;61(5):790-7. doi: 10.1053/j.ajkd.2012.08.049. Epub 2012 Dec 20.
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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.
Lorenzo Gallon, MD principal investigator
Northwestern University
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 Complication of Transplant, run by Northwestern University at 1 site 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Sep 2018. 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 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 was stopped early (reason given: Due to a lack of laboratory resources, the study was abandoned.). Results are not available in the source record.
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?
Graft failure (time frame: 2 years post transplant). 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 NCT02514733, 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 25 Sep 2018.