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Hard-to-Place (HTP) Donor Kidneys for Organ Preservation (OPTIMAL Trial)

N/A
Recruiting
Led By Chris Jaynes
Research Sponsored by 34 Lives, PBC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up annually, up to 3-years post-transplant
Awards & highlights

OPTIMAL Trial Summary

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.

OPTIMAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~annually, up to 3-years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and annually, up to 3-years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Transplant Allocation Success
Secondary outcome measures
7-Day Delayed Graft Function (DGF)
Graft Survival
Long term data collection- Graft Survival
+6 more

OPTIMAL Trial Design

1Treatment groups
Experimental Treatment
Group I: Hard-to-Place (HTP) Donor KidneysExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

34 Lives, PBCLead Sponsor
University of MiamiOTHER
903 Previous Clinical Trials
410,116 Total Patients Enrolled
1 Trials studying Organ Preservation
300 Patients Enrolled for Organ Preservation
University of Wisconsin, MadisonOTHER
1,189 Previous Clinical Trials
3,169,511 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
2024. "A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06263023.
All > Miami > Milwaukee
~53 spots leftby Mar 2025
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