Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies

Kidney Transplant Clinical Trial

Official title:

Pilot Randomized Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837522
• Other study ID #: 29880
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: February 4, 2023

Study information

• Verified date: March 2023
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 4, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Death
• Kidney Transplant
• Renal Transplant

Intervention

Diagnostic Test:
• Procurement Biopsy: Frozen section
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 section
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.

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
St. Louis University	Mid-America Transplant, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

De 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. — View Citation

Hart 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. — View Citation

Hart 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. — View Citation

Husain 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. — View Citation

Kasiske 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. — View Citation

Naesens M. Zero-Time Renal Transplant Biopsies: A Comprehensive Review. Transplantation. 2016 Jul;100(7):1425-39. doi: 10.1097/TP.0000000000001018. — View Citation

Walker 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. — View Citation

Wang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 years
Secondary	Life years for transplant recipients	Life years or survival for candidates after offer of kidney with an immediate vs delayed procurement biopsy processing	3 years
Secondary	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	3 years
Secondary	Number of participants with graft survival	Number of participants with graft survival after transplant of kidney with an immediate vs delayed procurement biopsy processing	3 years
Secondary	Cold ischemia time	Cold ischemia time for kidneys transplanted after immediate vs delayed procurement biopsy processing	3 years
Secondary	Patient survival after transplant	Patient survival after transplant of kidney with an immediate vs delayed procurement biopsy processing	3 years

External Links

•   Eurotransplant Statistics Report Library.
•   National Kidney Foundation. Progress: Discarding a kidney can discard a life. Overview of Consensus Conference to Decrease Kidney Discards.