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

Not Applicable

Completed

• Conditions: Renal Transplant; Kidney Transplant

• Registration Number: NCT03837522
• Lead Sponsor: St. Louis University

Brief 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.

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 Timeline

• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2019-09-17
• Primary Completion: 2022-06-30
• Study Completion: 2023-02-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
risk-adjusted kidney yield	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)

Secondary Outcome Measures

Name	Time	Method
Number of participants with graft survival	3 years	Number of participants with graft survival after transplant of kidney with an immediate vs delayed procurement biopsy processing
Cold ischemia time	3 years	Cold ischemia time for kidneys transplanted after immediate vs delayed procurement biopsy processing
Number of participants with delayed graft function	3 years	Number of participants with delayed graft function after transplant of kidney with an immediate vs delayed procurement biopsy processing
Life years for transplant recipients	3 years	Life years or survival for candidates after offer of kidney with an immediate vs delayed procurement biopsy processing
Patient survival after transplant	3 years	Patient survival after transplant of kidney with an immediate vs delayed procurement biopsy processing

Trial Locations

Locations (2)

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States