NCT03837522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

September 17, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

February 8, 2019

Last Update Submit

March 28, 2023

Conditions

Kidney TransplantRenal Transplant

Keywords

BiopsyDeceased kidney donationKidney transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Life years for transplant recipients

    3 years

  • Number of participants with delayed graft function

    3 years

  • Number of participants with graft survival

    3 years

  • Cold ischemia time

    3 years

  • Patient survival after transplant

    3 years

Study Arms (2)

Procurement Biopsy: Frozen section

ACTIVE COMPARATOR

In the routine care condition, biopsies will be processed immediately as a frozen section.

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.

Diagnostic Test: Procurement Biopsy: Permanent section

Interventions

Procurement Biopsy: Frozen sectionDIAGNOSTIC_TEST

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.

Also known as: Immediate results
Procurement Biopsy: Frozen section
Procurement Biopsy: Permanent sectionDIAGNOSTIC_TEST

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.

Also known as: Delayed results
Procurement Biopsy: Permanent section

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (10)

  • 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.

    PMID: 30345720BACKGROUND

  • 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.

    PMID: 25772854BACKGROUND

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

    PMID: 26599490BACKGROUND

  • 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.

    PMID: 28052609BACKGROUND

  • 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.

    PMID: 23949799BACKGROUND

  • 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.

    PMID: 24558053BACKGROUND

  • 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.

    PMID: 29217537BACKGROUND

  • 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.

    PMID: 29292608BACKGROUND

  • 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.

    PMID: 15272280BACKGROUND

  • Lentine 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.

    PMID: 34045315DERIVED

Related Links

Study Officials

  • Krista Lentine, MD, PhD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 12, 2019

Study Start

September 17, 2019

Primary Completion

June 30, 2022

Study Completion

February 4, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

US(2)