Renal Failure ChronicEndoPreKiTNCT06677437
Endovascular Preparation for Kidney Tranplantation
An observational study of Renal Failure Chronic and Kidney Transplant, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This national study is a feasibility study. It wants to validate all stages of the endovascular preparation of the iliac axis up to the kidney transplant for patients in whom the installation of a tailor-made endoprosthesis was necessary beforehand. These patients are currently at a therapeutic impasse. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Failure Chronic, Kidney Transplant
- What is being tested?
- This is an observational and retrospective study
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study concerns adult patients with chronic renal failure who are all awaiting a kidney transplant, whether or not they are treated by extra-renal purification. These patients are contraindicated for transplantation due to their anatomical constraints: major arterial calcifications, iliac dissections, iliac stenoses and They can only receive the kidney transplant after arterial preparation.
Who may be able to join
- Patient from 18 to 85 years old (beyond 85 years old, guidance must remain exceptional)
- Patients with chronic renal failure
- Waiting for a kidney transplant
- Who have a vascular contraindication to renal transplantation because of their anatomical constraints.
Who cannot join
- 1-All criteria contraindicating kidney transplant other than for arterial anatomical problems: All criteria contraindicating kidney transplant other than for arterial anatomical problems:
- A progressive cancer, which is not cured,
- An uncontrolled infectious disease,
- Severe cardiovascular or respiratory disease making general anesthesia impossible,
- Unstabilized psychiatric disorders or illness,
- Dementia proven to have progressed after specialist advice
- Major obesity, with a body mass index greater than 50 kg/m2
- Patient refusal 2. Patient under curatorship 3. Pregnant woman 4. Patients for whom it will not be possible to organize regular medical follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
HCL Hopital Louis Pradel
Bron, 69500
Mathieu ARSICOT, 0472117804, mathieu.arsicot@chu-lyon.fr
Stephan HAULON
About this study
This national study is a feasibility study. It wants to validate all stages of the endovascular preparation of the iliac axis up to the kidney transplant for patients in whom the installation of a tailor-made endoprosthesis was necessary beforehand.
These patients are currently at a therapeutic impasse. This strategy of renal transplantation on an iliac artery endoprosthesis could ultimately give them access to the transplant with an improvement in quality of life and survival, for lower costs of care for the hospital and safety. less social than treatment by hemodialysis
- Conditions
- Renal Failure Chronic, Kidney Transplant
- Being tested
- This is an observational and retrospective study
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational and retrospective studyOther
It concerns all patients with chronic renal failure awaiting a kidney transplant, and presenting a contraindication to the transplant due to their anatomical constraints: major arterial calcifications, iliac dissections, iliac stenoses. They can only receive the kidney transplant after arterial preparation. These patients will be included and will benefit from endovascular preparation for the kidney transplant using a tailor-made arterial stent.
Imaging examinations and follow-up clinical data will be analyzed. Reinterventions and causes of death will be analyzed.
An information sheet will be given to patients; if the patient refuses the use of their data, it will not be collected.
Data collection will be carried out by ARCs or PIs of the centers from medical records. The data will be pseudo-anonymized, entered into a REDCAP database shared between each center.
| Study group | Role | What they receive |
|---|---|---|
| single group of adult patients with chronic renal failure who are all awaiting a kidney transplant | This study focuses on a single group of adult patients with chronic renal failure who are all awaiting a kidney transplant, whether or not they are treated by extra-renal purification.
These patients are contraindicated for transplantation due to their anatomical constraints: major arterial calcifications, iliac dissections, iliac stenoses and They can only receive the kidney transplant after arterial preparation. Receives: Other: This is an observational and retrospective study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the success of endovascular arterial preparation for grafting Renal.
The success of arterial preparation for renal transplantation will be evaluated by:
- Collect safety estimators, absence of serious complications (hemorrhage, acute/subacute ischemia of the lower limb, death, serious post-operative cardiorespiratory event, failure of renal function for non-dialysis patients) Validity at 1 month of an endovascular preparation for renal transplantation by tailor-made arterial stent by the success of the installation, the absence of endoleak and the good anteroposterior positioning of the stent
- Effectiveness at 1 month of endovascular preparation for renal transplantation by tailor-made arterial stent by permeability confirmed by Doppler ultrasound
Measured: "From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2024
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure ChronicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677437
- Sponsor's protocol ID
- 69HCL23_5431
- Acronym
- EndoPreKiT
- Status last verified
- Nov 2024
- First submitted
- 17 Jun 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Preparation for Kidney Tranplantation
- ClinicalTrials.gov ID
- NCT06677437
- Acronym / sponsor ID
- EndoPreKiT / 69HCL23_5431
- Conditions
- Renal Failure Chronic, Kidney Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 6 Nov 2024 (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.
This national study is a feasibility study. It wants to validate all stages of the endovascular preparation of the iliac axis up to the kidney transplant for patients in whom the installation of a tailor-made endoprosthesis was necessary beforehand.
These patients are currently at a therapeutic impasse. This strategy of renal transplantation on an iliac artery endoprosthesis could ultimately give them access to the transplant with an improvement in quality of life and survival, for lower costs of care for the hospital and safety. less social than treatment by hemodialysis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group of adult patients with chronic renal failure who are all awaiting a kidney transplant | – | Other: This is an observational and retrospective studyThis study focuses on a single group of adult patients with chronic renal failure who are all awaiting a kidney transplant, whether or not they are treated by extra-renal purification. These patients are contraindicated for transplantation due to their anatomical constraints: major arterial calcifications, iliac dissections, iliac stenoses and They can only receive the kidney transplant after arterial preparation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns adult patients with chronic renal failure who are all awaiting a kidney transplant, whether or not they are treated by extra-renal purification. These patients are contraindicated for transplantation due to their anatomical constraints: major arterial calcifications, iliac dissections, iliac stenoses and They can only receive the kidney transplant after arterial preparation.
Key inclusion criteria (4 listed)
- Patient from 18 to 85 years old (beyond 85 years old, guidance must remain exceptional)
- Patients with chronic renal failure
- Waiting for a kidney transplant
- Who have a vascular contraindication to renal transplantation because of their anatomical constraints.
Key exclusion criteria (8 listed)
- 1-All criteria contraindicating kidney transplant other than for arterial anatomical problems: All criteria contraindicating kidney transplant other than for arterial anatomical problems:
- A progressive cancer, which is not cured,
- An uncontrolled infectious disease,
- Severe cardiovascular or respiratory disease making general anesthesia impossible,
- Unstabilized psychiatric disorders or illness,
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 |
|---|---|---|
| This is an observational and retrospective studyIt concerns all patients with chronic renal failure awaiting a kidney transplant, and presenting a contraindication to the transplant due to their anatomical constraints: major arterial calcifications, iliac dissections, iliac stenoses. They can only receive the kidney transplant after arterial preparation. These patients will be included and will benefit from endovascular preparation for the kidney transplant using a tailor-made arterial stent. Imaging examinations and follow-up clinical data will be analyzed. Reinterventions and causes of death will be analyzed. An information sheet will be given to patients; if the patient refuses the use of their data, it will not be collected. Data collection will be carried out by ARCs or PIs of the centers from medical records. The data will be pseudo-anonymized, entered into a REDCAP database shared between each center. | Other | single group of adult patients with chronic renal failure who are all awaiting a kidney transplant |
Primary outcome
Evaluate the success of endovascular arterial preparation for grafting Renal.
Time frame: "From enrollment to the end of treatment at 12 months
The success of arterial preparation for renal transplantation will be evaluated by: * Collect safety estimators, absence of serious complications (hemorrhage, acute/subacute ischemia of the lower limb, death, serious post-operative cardiorespiratory event, failure of renal function for non-dialysis patients) Validity at 1 month of an endovascular preparation for renal transplantation by tailor-made arterial stent by the success of the installation, the absence of endoleak and the good anteroposterior positioning of the stent * Effectiveness at 1 month of endovascular preparation for renal transplantation by tailor-made arterial stent by permeability confirmed by Doppler ultrasound
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure Chronic and Kidney Transplant, run by Hospices Civils de Lyon at 1 site 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 8 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: looking for participants now, as of the sponsor's last update on 6 Nov 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the success of endovascular arterial preparation for grafting Renal. (time frame: "From enrollment to the end of treatment at 12 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 6 Nov 2024.