TransplantationRENOMAPNCT02826213
Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient
An observational study of Transplantation and Kidney, run by University Hospital, Tours at 7 sites in France.
Trial summary
Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Transplantation, Kidney
- What is being tested?
- LifePort® perfusion device and Waves perfusion device
- Type of treatment
- Medical device
- How many people
- 228 participants
- Where
- 7 sitesFrance
- Study dates
- 29 Nov 2017to 1 Sep 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RENAL Donors and recipients
Who may be able to join
- Deceased donor in brain-dead
- Donor presenting the expanded criteria of kidney removal (ECD criteria: elderly over 60 or aged 50 to 59 years and has two of the three following criteria: hypertension, stroke deaths, serum creatinine> 1.5 mg / dL)
- Possibility of both kidneys perfused machines
- Sampling of both kidneys, for two distinct recipients
Who cannot join
- none
- RENAL recipients:
- The grafts are addressed to transplant centers in France according to the distribution rules of the National Center of Distribution of transplants . (Pôle National de Répartition des Greffons (PNRG).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS
Angers, 49933
Coordination Hospitalière de PMO-Anestésiste -réanimateur, CHU-Bordeaux -GROUPE HOSPITALIER PELLEGRIN DAR I
Bordeaux, 33076
CHD-Vendée-Les Oudairies
La Roche-sur-Yon, 85925
Coordination des prélèvements d'organes et de Tissus- CHU-Limoges -CHU- DUPUYTREN
Limoges, 84042
Chirurgien-Chirurgie de la transplantation et d'Urologie, Pavillon V, Hôpital Edouard HERRIOT
Lyon, 69003
Coordination des prélèvements d'organes et de Tissus,CHU-NANTES
Nantes, 44093
Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital
Tours, 37044
About this study
Official title: Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial
Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial
Read the detailed description
Both machines differ in their operation: the LifePort® machine manufactured by the "Organ Recovery System (ORS)," says renal perfusion by maintaining a continuous perfusion pressure that is adjustable, while the Waves machine company "Medical Waters" assures infusion maintaining a controlled pulsatile flow.
Both machines are now available but the investigators currently have no study of whether an infusion type is superior to the other in terms of results on renal function recipients.
Study the impact of both types of infusion on renal function recipients evaluated in the early days of transplantation, at three months and one year after the transplant.
- Conditions
- Transplantation, Kidney
- Being tested
- LifePort® perfusion device, Waves perfusion device
- Keywords
- Renal infusion, Renal infusion device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifePort® perfusion deviceDevice
Also called A
Renal Perfusion with LifePort® perfusion device
Waves perfusion deviceDevice
Also called B
Renal Perfusion with Waves perfusion device
| Study group | Role | What they receive |
|---|---|---|
| Kidney : perfusion device lifeport | Each donor (n=140) will provide one kidney for pulsatile perfusion. Receives: Device: LifePort® perfusion device | |
| Kidney : perfusion device waves | Each donor (n=140) will provide one kidney for continuous perfusion. Receives: Device: Waves perfusion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate
Rate of patients with a Glomerular Filtration Rate (GFR) calculated by the MDRD ≥ 45 ml / min / 1,73m² (considered normal in a renal graft) at 3 months post-transplantation (MDRD: Modification of Diet in Renal the Disease)
Measured: 3 months
Secondary outcomes (5)
Creatinine <250 mg / dL
Time for obtaining a serum creatinine <250 mg / dL and need for dialysis in recovery during the first seven days post transplant.
Measured: 1 week
RFG
Absence of a recovery renal function at 1 month.
Measured: 1 month
MDRD
Modification of Diet in Renal the Disease at 1 year
Measured: 1 year
GSR
graft survival rate at 1 year.
Measured: 1 year
Renal Biopsie results
Results of analyzes of kidney biopsies punctures to 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start29 Nov 2017
- Primary completion1 Mar 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe VENHARD, MD-PhD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826213
- Sponsor's protocol ID
- PHRI14-JCV-RENOMAP
- Acronym
- RENOMAP
- Status last verified
- Nov 2022
- First submitted
- 5 Jul 2016
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial
- ClinicalTrials.gov ID
- NCT02826213
- Acronym / sponsor ID
- RENOMAP / PHRI14-JCV-RENOMAP
- Conditions
- Transplantation, Kidney
- Keywords
- Renal infusion, Renal infusion device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 7 Jul 2016 (estimated)
- 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.
Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial
Detailed description
Both machines differ in their operation: the LifePort® machine manufactured by the "Organ Recovery System (ORS)," says renal perfusion by maintaining a continuous perfusion pressure that is adjustable, while the Waves machine company "Medical Waters" assures infusion maintaining a controlled pulsatile flow.
Both machines are now available but the investigators currently have no study of whether an infusion type is superior to the other in terms of results on renal function recipients.
Study the impact of both types of infusion on renal function recipients evaluated in the early days of transplantation, at three months and one year after the transplant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney : perfusion device lifeport | – | Device: LifePort® perfusion deviceEach donor (n=140) will provide one kidney for pulsatile perfusion. |
| Kidney : perfusion device waves | – | Device: Waves perfusion deviceEach donor (n=140) will provide one kidney for continuous perfusion. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RENAL Donors and recipients
Key inclusion criteria (4 listed)
- Deceased donor in brain-dead
- Donor presenting the expanded criteria of kidney removal (ECD criteria: elderly over 60 or aged 50 to 59 years and has two of the three following criteria: hypertension, stroke deaths, serum creatinine> 1.5 mg / dL)
- Possibility of both kidneys perfused machines
- Sampling of both kidneys, for two distinct recipients
Key exclusion criteria (3 listed)
- none
- The grafts are addressed to transplant centers in France according to the distribution rules of the National Center of Distribution of transplants . (Pôle National de Répartition des Greffons (PNRG).
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® perfusion deviceAlso: ARenal Perfusion with LifePort® perfusion device | Device | Kidney : perfusion device lifeport |
| Waves perfusion deviceAlso: BRenal Perfusion with Waves perfusion device | Device | Kidney : perfusion device waves |
Primary outcome
Glomerular Filtration Rate
Time frame: 3 months
Rate of patients with a Glomerular Filtration Rate (GFR) calculated by the MDRD ≥ 45 ml / min / 1,73m² (considered normal in a renal graft) at 3 months post-transplantation (MDRD: Modification of Diet in Renal the Disease)
5 secondary outcomes
Creatinine <250 mg / dL
Time frame: 1 week
RFG
Time frame: 1 month
MDRD
Time frame: 1 year
GSR
Time frame: 1 year
Renal Biopsie results
Time frame: 3 months
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 3 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Jean-Christophe VENHARD, MD-PhD study director
University Hospital, Tours
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplantation and Kidney, run by University Hospital, Tours at 7 sites in France.
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 4 inclusion and 3 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Glomerular Filtration Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2022.