Kidney TransplantNCT03837522
Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies
A study testing Procurement Biopsy: Frozen section and Procurement Biopsy: Permanent section in people with Kidney Transplant and Renal Transplant, run by St. Louis University at 2 sites in United States.
Trial summary
The purpose of this research study is to compare the impact of the availability of biopsy results at the time of organ offers on the use and outcomes of kidneys from deceased donors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Renal Transplant
- What is being tested?
- Procurement Biopsy: Frozen section and Procurement Biopsy: Permanent section
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Sep 2019to 4 Feb 2023
- 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
- Kidney transplant candidate
- On waitlist for kidney transplant at the time of informed consent at one of the participating sites
- Age 18 or older
- Willing and able to provide informed consent for participation in the study
Who cannot join
- Unable or unwilling to provide informed consent to participate in the study
- Younger than 18 years old
- Not on waitlist for kidney transplant at the time of informed consent at one of the participating centers
- Candidates for or recipients of multi-organ transplants (kidney along with another solid organ)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Saint Louis University
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
About this study
Official title: Pilot Randomized Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies
The purpose of this research study is to compare the impact of the availability of biopsy results at the time of organ offers on the use and outcomes of kidneys from deceased donors.
Read the detailed description
Randomization of biopsy processing will be performed at the level of the deceased donor.
If the participant agrees to be in this study and signs the informed consent, at the time that a kidney is accepted for them, the accepted deceased donor will be randomized, like a flip of a coin, to one of two groups.
- Group 1: biopsies will be processed immediately (routine "frozen section") and results will be available to clinical teams at the time of the organ offers. Frozen section refers to a process where tissue from the biopsy sample is prepared by freezing and then slicing the tissue sample. Importantly, it can be done in about 15 to 20 minutes. Frozen sections are done when an immediate answer is needed; however, the quality of the sample is not always optimal.
- Group 2: biopsies will be processed using "permanent sections" - these results will not be available until after the organ is transplanted. Permanent section refers to a process where tissue from the biopsy sample is prepared by placing the tissue sample in a fixative, called formalin, to preserve the tissue, processing it through other additional solutions, and then placing it in paraffin wax. After the wax hardens, the tissue is cut into very thin slices, which are placed on slides and stained. This process normally takes several days.
There is a 50/50 chance that the donor will be randomized to immediate biopsy processing by frozen section, versus permanent processing that yields results after transplant. If for any reason their surgeon feels that it would not be safe to proceed without the biopsy result, he or she will have the ability to receive the results of the biopsy before the transplant. The study team will record any episodes of this occurrence.
- Conditions
- Kidney Transplant, Renal Transplant
- Being tested
- Procurement Biopsy: Frozen section, Procurement Biopsy: Permanent section
- Keywords
- Biopsy, Deceased kidney donation, Kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procurement Biopsy: Frozen sectionDiagnostic test
Also called Immediate results
Frozen sections are prepared by freezing and slicing the tissue sample; importantly, they can be done in about 15 to 20 minutes. Frozen sections are done when an immediate answer is needed, but do not provide optimal quality.
Procurement Biopsy: Permanent sectionDiagnostic test
Also called Delayed results
Permanent sections are prepared by placing the tissue in fixative (usually formalin) to preserve the tissue, processing it through additional solutions, and then placing it in paraffin wax. After the wax has hardened, the tissue is cut into very thin slices, which are placed on slides and stained. The process normally takes several days.
| Study group | Role | What they receive |
|---|---|---|
| Procurement Biopsy: Frozen section | Active comparator | In the routine care condition, biopsies will be processed immediately as a frozen section. Receives: Diagnostic Test: Procurement Biopsy: Frozen section |
| Procurement Biopsy: Permanent section | Active comparator | In the intervention group, the biopsy processing will be delayed to permanent section, and therefore not available until allocation is complete. Receives: Diagnostic Test: Procurement Biopsy: Permanent section |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk-adjusted kidney yield
per kidney donor with an immediate vs delayed procurement biopsy processing (this will serve as the primary organ utilization metric, and is the adjusted converse of organ discard)
Measured: 3 years
Secondary outcomes (5)
Life years for transplant recipients
Life years or survival for candidates after offer of kidney with an immediate vs delayed procurement biopsy processing
Measured: 3 years
Number of participants with delayed graft function
Number of participants with delayed graft function after transplant of kidney with an immediate vs delayed procurement biopsy processing
Measured: 3 years
Number of participants with graft survival
Number of participants with graft survival after transplant of kidney with an immediate vs delayed procurement biopsy processing
Measured: 3 years
Cold ischemia time
Cold ischemia time for kidneys transplanted after immediate vs delayed procurement biopsy processing
Measured: 3 years
Patient survival after transplant
Patient survival after transplant of kidney with an immediate vs delayed procurement biopsy processing
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start17 Sep 2019
- Primary completion30 Jun 2022
- Study completion4 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- Mid-America Transplant, Washington University School of Medicine
- Responsible party
- Principal investigator, Krista Lentine MD, PhD, St. Louis University
- Investigators
- Krista Lentine, MD, PhD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837522
- Sponsor's protocol ID
- 29880
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2019
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cooper M, Formica R, Friedewald J, Hirose R, O'Connor K, Mohan S, Schold J, Axelrod D, Pastan S. Report of National Kidney Foundation Consensus Conference to Decrease Kidney Discards. Clin Transplant. 2019 Jan;33(1):e13419. doi: 10.1111/ctr.13419. Epub 2018 Oct 21.
PubMed 30345720Wang CJ, Wetmore JB, Crary GS, Kasiske BL. The Donor Kidney Biopsy and Its Implications in Predicting Graft Outcomes: A Systematic Review. Am J Transplant. 2015 Jul;15(7):1903-14. doi: 10.1111/ajt.13213. Epub 2015 Mar 13.
PubMed 25772854Naesens M. Zero-Time Renal Transplant Biopsies: A Comprehensive Review. Transplantation. 2016 Jul;100(7):1425-39. doi: 10.1097/TP.0000000000001018.
PubMed 26599490Hart A, Smith JM, Skeans MA, Gustafson SK, Stewart DE, Cherikh WS, Wainright JL, Kucheryavaya A, Woodbury M, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2015 Annual Data Report: Kidney. Am J Transplant. 2017 Jan;17 Suppl 1(Suppl 1):21-116. doi: 10.1111/ajt.14124.
PubMed 28052609De Vusser K, Lerut E, Kuypers D, Vanrenterghem Y, Jochmans I, Monbaliu D, Pirenne J, Naesens M. The predictive value of kidney allograft baseline biopsies for long-term graft survival. J Am Soc Nephrol. 2013 Nov;24(11):1913-23. doi: 10.1681/ASN.2012111081. Epub 2013 Aug 15.
PubMed 23949799Kasiske BL, Stewart DE, Bista BR, Salkowski N, Snyder JJ, Israni AK, Crary GS, Rosendale JD, Matas AJ, Delmonico FL. The role of procurement biopsies in acceptance decisions for kidneys retrieved for transplant. Clin J Am Soc Nephrol. 2014 Mar;9(3):562-71. doi: 10.2215/CJN.07610713. Epub 2014 Feb 20.
PubMed 24558053Husain SA, Chiles MC, Lee S, Pastan SO, Patzer RE, Tanriover B, Ratner LE, Mohan S. Characteristics and Performance of Unilateral Kidney Transplants from Deceased Donors. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):118-127. doi: 10.2215/CJN.06550617. Epub 2017 Dec 7.
PubMed 29217537Hart A, Smith JM, Skeans MA, Gustafson SK, Wilk AR, Robinson A, Wainright JL, Haynes CR, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2016 Annual Data Report: Kidney. Am J Transplant. 2018 Jan;18 Suppl 1(Suppl 1):18-113. doi: 10.1111/ajt.14557.
PubMed 29292608Walker PD, Cavallo T, Bonsib SM; Ad Hoc Committee on Renal Biopsy Guidelines of the Renal Pathology Society. Practice guidelines for the renal biopsy. Mod Pathol. 2004 Dec;17(12):1555-63. doi: 10.1038/modpathol.3800239.
PubMed 15272280Lentine KL, Kasiske B, Axelrod DA. Procurement Biopsies in Kidney Transplantation: More Information May Not Lead to Better Decisions. J Am Soc Nephrol. 2021 Aug;32(8):1835-1837. doi: 10.1681/ASN.2021030403. Epub 2021 May 27. No abstract available.
PubMed 34045315
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies
- ClinicalTrials.gov ID
- NCT03837522
- Acronym / sponsor ID
- 29880
- Conditions
- Kidney Transplant, Renal Transplant
- Keywords
- Biopsy, Deceased kidney donation, Kidney transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- Mid-America Transplant, Washington University School of Medicine
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 4 Feb 2023 (actual)
- First posted
- 12 Feb 2019 (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 purpose of this research study is to compare the impact of the availability of biopsy results at the time of organ offers on the use and outcomes of kidneys from deceased donors.
Detailed description
Randomization of biopsy processing will be performed at the level of the deceased donor.
If the participant agrees to be in this study and signs the informed consent, at the time that a kidney is accepted for them, the accepted deceased donor will be randomized, like a flip of a coin, to one of two groups.
- Group 1: biopsies will be processed immediately (routine "frozen section") and results will be available to clinical teams at the time of the organ offers. Frozen section refers to a process where tissue from the biopsy sample is prepared by freezing and then slicing the tissue sample. Importantly, it can be done in about 15 to 20 minutes. Frozen sections are done when an immediate answer is needed; however, the quality of the sample is not always optimal.
- Group 2: biopsies will be processed using "permanent sections" - these results will not be available until after the organ is transplanted. Permanent section refers to a process where tissue from the biopsy sample is prepared by placing the tissue sample in a fixative, called formalin, to preserve the tissue, processing it through other additional solutions, and then placing it in paraffin wax. After the wax hardens, the tissue is cut into very thin slices, which are placed on slides and stained. This process normally takes several days.
There is a 50/50 chance that the donor will be randomized to immediate biopsy processing by frozen section, versus permanent processing that yields results after transplant. If for any reason their surgeon feels that it would not be safe to proceed without the biopsy result, he or she will have the ability to receive the results of the biopsy before the transplant. The study team will record any episodes of this occurrence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procurement Biopsy: Frozen section | Active comparator | Diagnostic Test: Procurement Biopsy: Frozen sectionIn the routine care condition, biopsies will be processed immediately as a frozen section. |
| Procurement Biopsy: Permanent section | Active comparator | Diagnostic Test: Procurement Biopsy: Permanent sectionIn the intervention group, the biopsy processing will be delayed to permanent section, and therefore not available until allocation is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Kidney transplant candidate
- On waitlist for kidney transplant at the time of informed consent at one of the participating sites
- Age 18 or older
- Willing and able to provide informed consent for participation in the study
Key exclusion criteria (4 listed)
- Unable or unwilling to provide informed consent to participate in the study
- Younger than 18 years old
- Not on waitlist for kidney transplant at the time of informed consent at one of the participating centers
- Candidates for or recipients of multi-organ transplants (kidney along with another solid organ)
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 |
|---|---|---|
| Procurement Biopsy: Frozen sectionAlso: Immediate resultsFrozen sections are prepared by freezing and slicing the tissue sample; importantly, they can be done in about 15 to 20 minutes. Frozen sections are done when an immediate answer is needed, but do not provide optimal quality. | Diagnostic test | Procurement Biopsy: Frozen section |
| Procurement Biopsy: Permanent sectionAlso: Delayed resultsPermanent sections are prepared by placing the tissue in fixative (usually formalin) to preserve the tissue, processing it through additional solutions, and then placing it in paraffin wax. After the wax has hardened, the tissue is cut into very thin slices, which are placed on slides and stained. The process normally takes several days. | Diagnostic test | Procurement Biopsy: Permanent section |
Primary outcome
risk-adjusted kidney yield
Time frame: 3 years
per kidney donor with an immediate vs delayed procurement biopsy processing (this will serve as the primary organ utilization metric, and is the adjusted converse of organ discard)
5 secondary outcomes
Life years for transplant recipients
Time frame: 3 years
Number of participants with delayed graft function
Time frame: 3 years
Number of participants with graft survival
Time frame: 3 years
Cold ischemia time
Time frame: 3 years
Patient survival after transplant
Time frame: 3 years
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 30 Mar 2023.
- Background: PubMed 30345720Cooper M, Formica R, Friedewald J, Hirose R, O'Connor K, Mohan S, Schold J, Axelrod D, Pastan S. Report of National Kidney Foundation Consensus Conference to Decrease Kidney Discards. Clin Transplant. 2019 Jan;33(1):e13419. doi: 10.1111/ctr.13419. Epub 2018 Oct 21.
- Background: PubMed 25772854Wang CJ, Wetmore JB, Crary GS, Kasiske BL. The Donor Kidney Biopsy and Its Implications in Predicting Graft Outcomes: A Systematic Review. Am J Transplant. 2015 Jul;15(7):1903-14. doi: 10.1111/ajt.13213. Epub 2015 Mar 13.
- Background: PubMed 26599490Naesens M. Zero-Time Renal Transplant Biopsies: A Comprehensive Review. Transplantation. 2016 Jul;100(7):1425-39. doi: 10.1097/TP.0000000000001018.
- Background: PubMed 28052609Hart A, Smith JM, Skeans MA, Gustafson SK, Stewart DE, Cherikh WS, Wainright JL, Kucheryavaya A, Woodbury M, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2015 Annual Data Report: Kidney. Am J Transplant. 2017 Jan;17 Suppl 1(Suppl 1):21-116. doi: 10.1111/ajt.14124.
- Background: PubMed 23949799De Vusser K, Lerut E, Kuypers D, Vanrenterghem Y, Jochmans I, Monbaliu D, Pirenne J, Naesens M. The predictive value of kidney allograft baseline biopsies for long-term graft survival. J Am Soc Nephrol. 2013 Nov;24(11):1913-23. doi: 10.1681/ASN.2012111081. Epub 2013 Aug 15.
- Background: PubMed 24558053Kasiske BL, Stewart DE, Bista BR, Salkowski N, Snyder JJ, Israni AK, Crary GS, Rosendale JD, Matas AJ, Delmonico FL. The role of procurement biopsies in acceptance decisions for kidneys retrieved for transplant. Clin J Am Soc Nephrol. 2014 Mar;9(3):562-71. doi: 10.2215/CJN.07610713. Epub 2014 Feb 20.
- Background: PubMed 29217537Husain SA, Chiles MC, Lee S, Pastan SO, Patzer RE, Tanriover B, Ratner LE, Mohan S. Characteristics and Performance of Unilateral Kidney Transplants from Deceased Donors. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):118-127. doi: 10.2215/CJN.06550617. Epub 2017 Dec 7.
- Background: PubMed 29292608Hart A, Smith JM, Skeans MA, Gustafson SK, Wilk AR, Robinson A, Wainright JL, Haynes CR, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2016 Annual Data Report: Kidney. Am J Transplant. 2018 Jan;18 Suppl 1(Suppl 1):18-113. doi: 10.1111/ajt.14557.
- Background: PubMed 15272280Walker PD, Cavallo T, Bonsib SM; Ad Hoc Committee on Renal Biopsy Guidelines of the Renal Pathology Society. Practice guidelines for the renal biopsy. Mod Pathol. 2004 Dec;17(12):1555-63. doi: 10.1038/modpathol.3800239.
- Derived from this study: PubMed 34045315Lentine KL, Kasiske B, Axelrod DA. Procurement Biopsies in Kidney Transplantation: More Information May Not Lead to Better Decisions. J Am Soc Nephrol. 2021 Aug;32(8):1835-1837. doi: 10.1681/ASN.2021030403. Epub 2021 May 27. No abstract available.
- National Kidney Foundation. Progress: Discarding a kidney can discard a life. Overview of Consensus Conference to Decrease Kidney Discards.Link provided by the sponsor.
- Eurotransplant Statistics Report Library.Link 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.
Krista Lentine, MD, PhD principal investigator
St. Louis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procurement Biopsy: Frozen section and Procurement Biopsy: Permanent section in people with Kidney Transplant and Renal Transplant, run by St. Louis University at 2 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 4 inclusion and 4 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 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
risk-adjusted kidney yield (time frame: 3 years). 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 NCT03837522, which also lists 10 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 30 Mar 2023.