NCT04569682

Brief Summary

The main objective of this study is to compare the outcomes of transrenal artery perfusion versus transrenal vein perfusion using LifePort for deceased donor kidney transplantation. Patients registered in the National Dialysis and Transplant Registry awaiting deceased donor kidney transplantation were included. Delayed graft function (DGF) or primary nonfunction (PNF) may occur after deceased donor kidney transplantation. Compared with static cold storage, the application of LifePort can significantly reduce the incidence of DGF and PNF in deceased donor kidney transplantation. Transrenal artery perfusion is currently the mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time. Transrenal vein perfusion is expected to be a solution. However, whether the clinical outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains unknown. In this study, values of urine volume and creatinine, incidence and duration of DGF, and incidence of PNF within 1 week after surgery are recorded and compared between the transrenal artery perfusion group and the transrenal vein perfusion group. Monthly eGFR and creatinine values, the incidence of acute rejection within 1 year after transplantation and 1-year graft and patient survival are also recorded and compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

September 21, 2020

Last Update Submit

May 19, 2023

Conditions

Kidney TransplantationOrgan Preservation

Outcome Measures

Primary Outcomes (1)

  • Delayed graft function

    Delayed graft function is defined as the need for dialysis (for any cause) within the first week posttransplantation.

    Within one week posttransplantation

Secondary Outcomes (2)

  • Graft loss

    One year after transplantation

  • biopsy-confirmed acute rejection

    One year after transplantation

Study Arms (2)

transrenal artery perfusion group

ACTIVE COMPARATOR
Device: LifePort transrenal artery perfusion

transrenal vein perfusion group

EXPERIMENTAL
Device: LifePort transrenal vein perfusion

Interventions

LifePort transrenal artery perfusionDEVICE

transrenal artery perfusion group

transrenal artery perfusion group
LifePort transrenal vein perfusionDEVICE

transrenal vein perfusion group

transrenal vein perfusion group

Eligibility Criteria

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

You may qualify if:

  • Adult recipients older than 18 years;
  • Patients diagnosed with end-stage renal diseases and volunteered to register in the Transplant and Dialysis Registry of China awaiting for deceased donor kidney transplantation;
  • First single kidney transplantation;
  • The recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent;
  • Ethics committee approved.

You may not qualify if:

  • Patients less than 18 years old, or more than 65 years old;
  • Patients who receive multiple organ transplants;
  • Diagnosed with malignancy or had a history of malignancy in the past 5 years;
  • non-kidney transplantation history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, China

Location

Related Publications (2)

  • Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.

    PMID: 38979743DERIVED

  • Zhang H, Zeng J, Fan Y, Ma M, Lin T, Song T. Continuous renal surface cooling technique (CSCT) in robotic-assisted kidney transplantation: technique and outcomes from a high-volume center: a prospective cohort study. Int J Surg. 2024 Jul 1;110(7):4143-4150. doi: 10.1097/JS9.0000000000001385.

    PMID: 38742842DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of the Organ Transplant Center

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 30, 2020

Study Start

January 1, 2020

Primary Completion

October 30, 2021

Study Completion

December 30, 2022

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations

CN(1)