A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation (OPTIMAL)

April 23, 2024 updated by: 34 Lives, PBC

An Observational Study of a Dedicated Preservation and Assessment Service to Optimize Organ Utilization for Hard-to-Place Kidneys

This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an Observational study of a centralized kidney assessment facility providing brief sub-normothermic machine perfusion (SNMP) to HTP donor kidneys to provide transplant centers additional information for accepting HTP kidneys.

This study is intended to collect data to evaluate the feasibility of a dedicated central service to determine if additional assessment data helps increase allocation to transplant centers. Transplantation will follow standard-of-care at each transplant center, including required post-transplant data collection, which must be reported to the OPTN registry by the center.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • Miami Transplant Institute, University of Miami Miller School of Medicine
        • Principal Investigator:
          • Giselle Guerra, MD
        • Contact:
          • Giselle Guerra, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health
        • Contact:
          • William Goggins, MD
        • Principal Investigator:
          • William Goggins, MD
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Hospital
        • Contact:
          • Matthew Holzner, MD
        • Principal Investigator:
          • Matthew Holzner, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • University of Wisconsin School of Medicine and Public Health
        • Contact:
          • Jacqueline Garonzik Wang, MD
        • Principal Investigator:
          • Jacqueline Garonzik Wang, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes hard-to-place (HTP) deceased donor kidneys retrieved from donation after brain death (DBD) and donation after circulatory death (DCD) donors aged 16- 75.

Description

Donor Kidney Inclusion Criteria:

  • Be considered HTP, by receiving refusals from every transplant center within the 250 nm allocation radius or similar definition by the local OPO.
  • From a Male or female deceased donor, aged 16- 75 years old.
  • Kidney initially procured, preserved, and packaged with intent to transplant.
  • LAP provides informed consent for organ donation for transplant and research purposes.
  • The HTP donor kidney must be allocated to a participating transplant center by a participating OPO, and the transplant center makes the decision to send kidney to Sponsor's central preservation and assessment facility for SNMP assessment and preservation prior to determining suitability for allocation.

Donor Kidney Exclusion Criteria:

  • From a Donor with pre-admission diagnosis of end stage renal failure.
  • Obvious surgical damage to artery(s), vein(s), or ureter(s) preventing machine perfusion.
  • From a donor with confirmed HIV (+), HBVSAg (+) and/or HCV NAT (+) serology results.
  • No LAP consent for both transplant and research purposes.
  • Cannot arrive to Sponsor's central preservation and assessment facility before reaching 24 hours of cold ischemic time (CIT).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hard-to-Place (HTP) Donor Kidneys
The study will be open to all eligible HTP kidneys from male and female donors at all participating Organ Procurement Organization (OPO) study sites. Consent for both organ donation for transplant and medical research will be obtained from the legally authorized party (LAP) by the OPO Coordinator using industry standard consent procedures and documents.
Other: Sub-Normothermic Machine Preservation and Assessment
Human kidneys from HTP deceased donors will be transported to the Sponsor's central preservation and assessment facility and placed onto a machine perfusion system in a sterile operating room for a brief period of Sub-Normothermic Machine Perfusion (SNMP). Basic parameters including internal renal resistance, oxygen, and electrolyte levels will be recorded using standard point-of-care hospital analyzers. Accepted kidneys will be transported to a participating transplant center using a portable oxygenated LifePort Hypothermic Machine Preservation (HMP) device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplant Allocation Success
Time Frame: 1 year
The primary objective for this study is a 50% success rate or higher for allocation of Hard-to-Place (HTP) kidneys to a participating transplant center after sNMP assessment at the Sponsor's central facility.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-Day Delayed Graft Function (DGF)
Time Frame: 7 days post-transplant
Requirement for dialysis within first 7 days post-transplant
7 days post-transplant
Graft Survival
Time Frame: 1- and 3-months post-transplant
Donor kidney survival
1- and 3-months post-transplant
Patient Survival
Time Frame: 1- and 3-months post-transplant
Recipient survival
1- and 3-months post-transplant
Serum Creatinine (sCr)
Time Frame: 1- and 3-months post-transplant
Recipient sCr
1- and 3-months post-transplant
eGFR
Time Frame: 1- and 3-months post-transplant
Recipient estimated glomerular filtration rate
1- and 3-months post-transplant
Long term data collection- Graft Survival
Time Frame: Annually, up to 3-years post-transplant
Graft survival
Annually, up to 3-years post-transplant
Long term data collection- Patient Survival
Time Frame: Annually, up to 3-years post-transplant
Patient survival
Annually, up to 3-years post-transplant
Long term data collection- Serum Creatinine
Time Frame: Annually, up to 3-years post-transplant
Recipient sCr
Annually, up to 3-years post-transplant
Long term data collection- eGFR
Time Frame: Annually, up to 3-years post-transplant
Recipient estimated glomerular filtration rate
Annually, up to 3-years post-transplant

Collaborators and Investigators

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

Sponsor

34 Lives, PBC

Collaborators

University of Miami
University of Wisconsin, Madison
MOUNT SINAI HOSPITAL
Indiana University Health

Investigators

  • Principal Investigator: Chris Jaynes, 34 Lives, PBC (Sponsor)

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

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)

April 19, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 34L-CP-02-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Standard data will be obtained from the Organ Procurement and Transplantation Network (OPTN), which is readily available to the public via request to the Health Resources Service Administration (HRSA), in de-identified form to protect privacy. These standard data include information about the organ donor, preservation procedure, the recipient's kidney transplant, and post-operative follow-up.

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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