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

March 28, 2023 updated by: Krista Lentine MD, PhD, St. Louis University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Procurement Biopsy: Frozen section
In the routine care condition, biopsies will be processed immediately as a frozen section.
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.
Other Names:
  • Immediate results
Active Comparator: Procurement Biopsy: Permanent section
In the intervention group, the biopsy processing will be delayed to permanent section, and therefore not available until allocation is complete.
Diagnostic test: 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.
Other Names:
  • Delayed results

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Collaborators

Washington University School of Medicine
Mid-America Transplant

Investigators

  • Principal Investigator: Krista Lentine, MD, PhD, St. Louis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2019

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

February 4, 2023

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 8, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29880

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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