Registry Analysis of Deceased Donor Kidney Transplant Out... | NCT07530991

Studies
Registry Analysis of Deceased Donor Kidney Transplant Outcomes

NCT07530991

Sponsor

Chris Jaynes

Status

Active, not recruiting

Last Update Posted

Apr 15, 2026Actual

Enrollment

3,500Estimated

Phase

Not provided

Conditions

Normothermic Machine Perfusion (NMP) of Deceased Donor Kidneys

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Actual

Primary Completion Date

Apr 30, 2029Estimated

Completion Date

Apr 30, 2029Estimated

First Submitted Date

Apr 4, 2026

First Submission Date that Met QC Criteria

Apr 11, 2026

First Posted Date

Apr 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2026

Last Update Posted Date

Apr 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes associated with normothermic machine perfusion (NMP) of deceased donor kidneys. Currently, there is no method to study NMP kidney outcomes using the National Scientific Registry for Transplant Recipients (SRTR) national public registry, because no data field exists to identify which kidneys received NMP.

Detailed Description

This is a retrospective observational study using existing data from the Scientific Registry of Transplant Recipients (SRTR)/ Organ Procurement and Transplant Network (OPTN) public registry following a Research Plan approved by Health Resources & Services Agency (HRSA).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NMP Kidney Recipients		Patients receiving a kidney preserved and assessed using NMP

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Delayed Graft Function	Requirement for dialysis immediately post kidney transplantation	7 days post-transplantation
Delayed Graft Function (DGF)	Requirement for dialysis within 7 days post kidney transplantation	7 days

Secondary Outcomes

Measure	Description	Time Frame
Serum creatinine	Serum creatinine level	Up to 3 years post-transplantation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Requires kidney transplantation

Exclusion Criteria:

> 15 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

End stage renal disease, receiving a kidney transplant.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henri Leuvenink, PhD	34 Lives, PBC	Study Chair
Jacqueline Garonzik-Wang, MD, PhD	University of Alabama at Birmingham	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
34 Lives, PBC		West Lafayette	Indiana	47906	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

This is a registry-only, Non Human Subjects Research (NHSR) study. No IPD information will be available to any investigator in this study.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided