Kidney TransplantationNCT04569682

Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation

A study testing LifePort transrenal artery perfusion and LifePort transrenal vein perfusion in people with Kidney Transplantation and Organ Preservation, run by West China Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Kidney Transplantation, Organ Preservation
What is being tested?: LifePort transrenal artery perfusion and LifePort transrenal vein perfusion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteChina
Study dates: 1 Jan 2020to 30 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital, Sichuan University
Chengdu

Other trials in China

About this study

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.

Conditions: Kidney Transplantation, Organ Preservation
Being tested: LifePort transrenal artery perfusion, LifePort transrenal vein perfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LifePort transrenal artery perfusionDevice
transrenal artery perfusion group
LifePort transrenal vein perfusionDevice
transrenal vein perfusion group

Study groups in NCT04569682
Study group	Role	What they receive
transrenal artery perfusion group	Active comparator	Not described Receives: Device: LifePort transrenal artery perfusion
transrenal vein perfusion group	Experimental	Not described Receives: Device: LifePort transrenal vein perfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Graft loss
Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of <15 ml/min.
Measured: One year after transplantation
biopsy-confirmed acute rejection
biopsy-confirmed acute rejection was diagnosed clinically based on a significant increase in serum creatinine levels of 50% or more within 3 days, which was not explained by other reasons and confirmed by biopsy.
Measured: One year after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202030 Dec 2022

First posted30 Sep 2020
Study start1 Jan 2020
Primary completion30 Oct 2021
Study completion30 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Kidney TransplantationStudies of the same condition, open and under way.
More trials run by West China HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04569682
Sponsor's protocol ID: WestChina-LifePort
Status last verified: May 2023
First submitted: 21 Sep 2020
Last updated: 22 May 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 38979743
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.
PubMed 38742842

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney

All Kidney Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation
ClinicalTrials.gov ID: NCT04569682
Acronym / sponsor ID: WestChina-LifePort
Conditions: Kidney Transplantation, Organ Preservation
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: West China HospitalUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 30 Oct 2021 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 30 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
transrenal artery perfusion group	Active comparator	Device: LifePort transrenal artery perfusion
transrenal vein perfusion group	Experimental	Device: LifePort transrenal vein perfusion

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LifePort transrenal artery perfusiontransrenal artery perfusion group	Device	transrenal artery perfusion group
LifePort transrenal vein perfusiontransrenal vein perfusion group	Device	transrenal vein perfusion group

Primary outcome

Delayed graft function
Time frame: Within one week posttransplantation
Delayed graft function is defined as the need for dialysis (for any cause) within the first week posttransplantation.

2 secondary outcomes

Graft loss
Time frame: One year after transplantation
biopsy-confirmed acute rejection
Time frame: One year after transplantation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
Derived from this study: PubMed 38979743Tingle 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.
Derived from this study: PubMed 38742842Zhang 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.
Individual participant dataSharing planned: Undecided

Related trials for Kidney Transplantation

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delayed graft function (time frame: Within one week posttransplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04569682, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.