Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys (HMPO2)

May 22, 2024 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

A Prospective Feasibility Trail to Compare the Efficacy of Intermittent Surface Oxygenation With Continuous Surface Oxygenation During Hypothermic Machine Perfusion of Kidneys Donated After Circulatory Death

The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Listed for a renal transplantation due to end stage renal disease
  • Willingness to comply with the protocol procedures for the duration of the study included scheduled follow-up visits and examinations.

Exclusion Criteria:

  • Multi-organ recipients
  • Dual kidney transplantation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: I-HMPO2
intermittent surface oxygenation during hypothermic machine perfusion (surface oxygenation interrupted during organ transport)
Drug: Oxygen
Active oxygenation during hypothermic machine perfusion by bubble and surface oxygenation. Intermittent surface oxygenation is compared with continuous surface oxygenation during hypothermic machine perfusion
Other Names:
  • feasibility of bubble and surface oxygenation applied to the LifePort Kidney Transporter (Organ Recovery Systems, Diegem, Belgium)
Active Comparator: C-HMPO2
continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)
Drug: Oxygen
Active oxygenation during hypothermic machine perfusion by bubble and surface oxygenation. Intermittent surface oxygenation is compared with continuous surface oxygenation during hypothermic machine perfusion
Other Names:
  • feasibility of bubble and surface oxygenation applied to the LifePort Kidney Transporter (Organ Recovery Systems, Diegem, Belgium)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional delayed graft function
Time Frame: first 7 days after transplantation
defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation (not including patients in whom acute rejection of calcineurin inhibitor toxicity is proven on biopsy)
first 7 days after transplantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Need for dialysis after transplantation
Time Frame: 0-30 days after transplantation
Number of dialysis sessions after transplantation
0-30 days after transplantation
Delayed graft function
Time Frame: first 7 days after transplantation
defined as the need for dialysis in the first 7 days after transplantation and preceding the return of kidney function
first 7 days after transplantation
Serum creatinine reduction ratio
Time Frame: Day 1-2 after transplantation
alternative definition of DGF= CRR2 < or = 30%
Day 1-2 after transplantation
Graft survival
Time Frame: From 1-365 days after transplantation
Functional kidney graft at 7 days, 3, 6, and 12 months
From 1-365 days after transplantation
Patient survival (censored and uncensored for death)
Time Frame: From 1-365 days after transplantation
Patient survival at 7 days, 3, 6, and 12 months
From 1-365 days after transplantation
Glomerular filtration rate at 1 year after transplantation
Time Frame: At 1 year after transplantation (window 30 days)
24-hour creatinine clearance
At 1 year after transplantation (window 30 days)
Estimated glomerular filtration rate
Time Frame: At 3, 6, and 12 months after transplantation with window of 10 days
eGFR defined by the CKD-EPI equation (Chronic Kidney Disease Epidemiology Collaboration) at 3, 6 and 12 months after transplantation
At 3, 6, and 12 months after transplantation with window of 10 days
Primary non-function
Time Frame: Until 3 months after transplantation
defined as the continued need for dialysis at 3 months after transplantation
Until 3 months after transplantation
Biopsy-proven acute rejection
Time Frame: Until 1 year after transplantation with window of 10 days
Biopsy-proven acute rejection during the 1 year after transplantation
Until 1 year after transplantation with window of 10 days
Metabolic analysis on kidney preservation tissue
Time Frame: Baseline and pre-surgery
Metabolic analysis by 1D proton NMR (e.g., succinate, lactate, acetate, formate, hypoxanthine) on a tissue sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney
Baseline and pre-surgery
Metabolic analysis on kidney preservation tissue
Time Frame: Baseline and pre-surgery
Metabolic analysis by liquid chromatography coupled to electrospray ionization mass spectrometry (LC-ESI-MS) (succinate, glutamate, lactate, ATP, ADP, AMP, NADH, NAD+) on a tissue sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney
Baseline and pre-surgery
Metabolic analysis on preservation fluid
Time Frame: Baseline and pre-surgery
Metabolic analysis by 1D proton NMR and fluorescence on a perfusion fluid sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney
Baseline and pre-surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tom Darius, MD, PhD, Cliniques universitaires Saint-Luc

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/21MAI/239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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