Graft FailureRENAGRAFNCT06191146
Factors for Impairment of Renal Graft Function in Intensive Care
An observational study of Graft Failure and Dialysis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
hypothesis = hospitalization in the intensive care unit (ICU) has an impact on the outcome of the renal graft, due to the therapeutic and exploratory procedures performed. the aim is to identify risk factors for renal graft degradation in the ICU up to 2 years after hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Graft Failure, Dialysis, Chronic Kidney Failure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Feb 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: non-dialyzed kidney transplant patient hospitalized in intensive care unit
Who may be able to join
- kidney graft
- > 18 years
- first hospitalization in ICU
Who cannot join
- chronic hemodialysis before ICU
- transfer to intensive care immediately after transplant within 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
hypothesis = hospitalization in the intensive care unit (ICU) has an impact on the outcome of the renal graft, due to the therapeutic and exploratory procedures performed.
the aim is to identify risk factors for renal graft degradation in the ICU up to 2 years after hospitalization.
Optimization of renal graft management in the ICU and management by nephrologists after the ICU
- Conditions
- Graft Failure, Dialysis, Chronic Kidney Failure
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
composite: return to dialysis, decline in GFR < 15 ml/min, death at 2 years
Death within 2 years, glomerular filtration rate < 15mL/min, need for dialysis
Measured: 2 years after ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft FailureStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gibot Sébastien, Central Hospital, Nancy, France
- Investigators
- Sébastien GIBOT, Principal investigator, CHU NANCY Central
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191146
- Sponsor's protocol ID
- 2023PI048
- Acronym
- RENAGRAF
- Status last verified
- Feb 2024
- First submitted
- 20 Dec 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors for Impairment of Renal Graft Function in Intensive Care
- ClinicalTrials.gov ID
- NCT06191146
- Acronym / sponsor ID
- RENAGRAF / 2023PI048
- Conditions
- Graft Failure, Dialysis, Chronic Kidney Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 5 Jan 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.
hypothesis = hospitalization in the intensive care unit (ICU) has an impact on the outcome of the renal graft, due to the therapeutic and exploratory procedures performed.
the aim is to identify risk factors for renal graft degradation in the ICU up to 2 years after hospitalization.
Optimization of renal graft management in the ICU and management by nephrologists after the ICU
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- non-dialyzed kidney transplant patient hospitalized in intensive care unit
Key inclusion criteria (3 listed)
- kidney graft
- > 18 years
- first hospitalization in ICU
Key exclusion criteria (2 listed)
- chronic hemodialysis before ICU
- transfer to intensive care immediately after transplant within 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composite: return to dialysis, decline in GFR < 15 ml/min, death at 2 years
Time frame: 2 years after ICU
Death within 2 years, glomerular filtration rate < 15mL/min, need for dialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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(TNX-1500) in Kidney Transplant Recipients
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A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
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ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
Kidney Transplant Failure and Rejection, Kidney Transplant; Complications
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.
Sébastien GIBOT principal investigator
CHU NANCY Central
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 Graft Failure and Dialysis, run by Central Hospital, Nancy, France 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact charles ZAGOZDA (0684130446, charles-zagozda@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite: return to dialysis, decline in GFR < 15 ml/min, death at 2 years (time frame: 2 years after ICU). 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 8 Feb 2024.