Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient
RENOMAP
1 other identifier
observational
228
1 country
7
Brief Summary
Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedStudy Start
First participant enrolled
November 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedNovember 3, 2022
November 1, 2022
3.3 years
July 5, 2016
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
3 months
Secondary Outcomes (5)
Creatinine <250 mg / dL
1 week
RFG
1 month
MDRD
1 year
GSR
1 year
Renal Biopsie results
3 months
Study Arms (2)
Kidney : perfusion device lifeport
Each donor (n=140) will provide one kidney for pulsatile perfusion.
Kidney : perfusion device waves
Each donor (n=140) will provide one kidney for continuous perfusion.
Interventions
Renal Perfusion with LifePort® perfusion device
Renal Perfusion with Waves perfusion device
Eligibility Criteria
RENAL Donors and recipients
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS
Angers, 49933, France
Coordination Hospitalière de PMO-Anestésiste -réanimateur, CHU-Bordeaux -GROUPE HOSPITALIER PELLEGRIN DAR I
Bordeaux, 33076, France
CHD-Vendée-Les Oudairies
La Roche-sur-Yon, 85925, France
Coordination des prélèvements d'organes et de Tissus- CHU-Limoges -CHU- DUPUYTREN
Limoges, 84042, France
Chirurgien-Chirurgie de la transplantation et d'Urologie, Pavillon V, Hôpital Edouard HERRIOT
Lyon, 69003, France
Coordination des prélèvements d'organes et de Tissus,CHU-NANTES
Nantes, 44093, France
Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital
Tours, 37044, France
Study Officials
- STUDY DIRECTOR
Jean-Christophe VENHARD, MD-PhD
University Hospital, Tours
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2016
First Posted
July 7, 2016
Study Start
November 29, 2017
Primary Completion
March 1, 2021
Study Completion
September 1, 2021
Last Updated
November 3, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share