Kidney Failure, ChronicNCT03007017
Novel Strategies for Innovating Deceased Donor Procurement
A study testing Deceased donor nephrectomy, prior to cross clamp of donor aorta in people with Kidney Failure, Chronic, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys available for transplantation and the number of patients on the transplant waiting list. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Deceased donor nephrectomy, prior to cross clamp of donor aorta
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 7 Jun 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently listed to receive a deceased donor kidney transplant
- Able to fully understand the informed consent document
- Recipient over the age of 18 years
Who cannot join
- Recipients undergoing a bilateral native nephrectomy at time of transplant
- Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant
- Individuals who are unable to understand the informed consent document
- Recipient under age 18 years
- Recipients receiving desensitization protocols for high levels of donor specific antibodies
Trial locations and contacts
1 site in 1 country.
About this study
Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys available for transplantation and the number of patients on the transplant waiting list. Increasing the quality of currently available donor kidneys would potentially improve the longevity of deceased donor kidney transplants by years, thus increasing the rate of transplantation patients on the kidney transplant waiting list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower total hospital charges. By innovating the organ donation process, such that deceased donor kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be possible to improve the quality of the kidney before transplantation, resulting in improved function after transplantation and increased longevity of these transplanted kidneys. Further, this improved kidney quality is highly likely to translate to reduced need for renal dialysis and other high-cost interventions, yielding lower total hospital charges. In this study we will test the hypothesis that, through a cost-free technical innovation, the quality of deceased donor kidneys could be improved significantly, saving thousands more lives per year and reducing total health care expenditures on renal transplantation.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Deceased donor nephrectomy, prior to cross clamp of donor aorta, Deceased donor nephrectomy, standard of care
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deceased donor nephrectomy, prior to cross clamp of donor aortaProcedure or surgery
The investigators will perform a prospective investigation of organ recoveries during which the left kidney will be removed prior to cessation of cardiac activity. The second kidney will be removed in the standard fashion. To do this, investigators will adopt techniques used in living donor kidney transplantation. Specifically, a specialized vascular stapler will be used to divide the renal artery at the level of aorta, followed by the vein, at the level of the vena cava. As such, no "cuff" of abdominal aorta or vena cava will be present on the target kidneys. Once removed from the body, just as is done for living donor kidney transplantation, the kidneys will be immediately flushed. As this ex-vivo flush is already performed for cadaveric kidney transplantation, there should be no additional cost for performing this portion of the procedure. Approximately 15 minutes of additional surgical dissection (prior to stopping the heart) will be required under the proposed study.
Deceased donor nephrectomy, standard of careProcedure or surgery
The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients selected for this arm will receive the left kidney from the new method of organ retrieval. Receives: Procedure: Deceased donor nephrectomy, prior to cross clamp of donor aorta |
| Arm 2 | Active comparator | Patients selected for this arm will receive the normal standard of care operational kidney from retrieval. Receives: Procedure: Deceased donor nephrectomy, standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequence of organ procurement
Renal allograft survival
Measured: 1 year
Kidney quality
Incidence of delayed renal graft function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Living Legacy Foundation
- Responsible party
- Principal investigator, Joseph Scalea, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007017
- Sponsor's protocol ID
- 00071879
- Status last verified
- Jun 2021
- First submitted
- 8 Dec 2016
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Strategies for Innovating Deceased Donor Procurement
- ClinicalTrials.gov ID
- NCT03007017
- Acronym / sponsor ID
- 00071879
- Conditions
- Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Living Legacy Foundation
- Study start
- Jan 2017 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 30 Dec 2016 (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.
Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys available for transplantation and the number of patients on the transplant waiting list. Increasing the quality of currently available donor kidneys would potentially improve the longevity of deceased donor kidney transplants by years, thus increasing the rate of transplantation patients on the kidney transplant waiting list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower total hospital charges. By innovating the organ donation process, such that deceased donor kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be possible to improve the quality of the kidney before transplantation, resulting in improved function after transplantation and increased longevity of these transplanted kidneys. Further, this improved kidney quality is highly likely to translate to reduced need for renal dialysis and other high-cost interventions, yielding lower total hospital charges. In this study we will test the hypothesis that, through a cost-free technical innovation, the quality of deceased donor kidneys could be improved significantly, saving thousands more lives per year and reducing total health care expenditures on renal transplantation.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Deceased donor nephrectomy, prior to cross clamp of donor aortaPatients selected for this arm will receive the left kidney from the new method of organ retrieval. |
| Arm 2 | Active comparator | Procedure: Deceased donor nephrectomy, standard of carePatients selected for this arm will receive the normal standard of care operational kidney from retrieval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently listed to receive a deceased donor kidney transplant
- Able to fully understand the informed consent document
- Recipient over the age of 18 years
Key exclusion criteria (5 listed)
- Recipients undergoing a bilateral native nephrectomy at time of transplant
- Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant
- Individuals who are unable to understand the informed consent document
- Recipient under age 18 years
- Recipients receiving desensitization protocols for high levels of donor specific antibodies
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 |
|---|---|---|
| Deceased donor nephrectomy, prior to cross clamp of donor aortaThe investigators will perform a prospective investigation of organ recoveries during which the left kidney will be removed prior to cessation of cardiac activity. The second kidney will be removed in the standard fashion. To do this, investigators will adopt techniques used in living donor kidney transplantation. Specifically, a specialized vascular stapler will be used to divide the renal artery at the level of aorta, followed by the vein, at the level of the vena cava. As such, no "cuff" of abdominal aorta or vena cava will be present on the target kidneys. Once removed from the body, just as is done for living donor kidney transplantation, the kidneys will be immediately flushed. As this ex-vivo flush is already performed for cadaveric kidney transplantation, there should be no additional cost for performing this portion of the procedure. Approximately 15 minutes of additional surgical dissection (prior to stopping the heart) will be required under the proposed study. | Procedure or surgery | Arm 1 |
| Deceased donor nephrectomy, standard of careThe investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation | Procedure or surgery | Arm 2 |
Primary outcome
Sequence of organ procurement
Time frame: 1 year
Renal allograft survival
Kidney quality
Time frame: 3 months
Incidence of delayed renal graft function
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 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deceased donor nephrectomy, prior to cross clamp of donor aorta in people with Kidney Failure, Chronic, run by University of Maryland, Baltimore 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 5 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 Jun 2021. 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 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?
Sequence of organ procurement (time frame: 1 year). 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?
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 Jun 2021.