Renal Transplantation; ComplicationABATNCT07917884
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
An observational study of Renal Transplantation; Complication and Renal Transplant, run by Nantes University Hospital at 1 site in France.
Trial summary
There is currently no consensus recommendation regarding the routine use of surveillance kidney allograft biopsies during the first year after transplantation. As a result, the decision to perform surveillance biopsies remains center-dependent, and their long-term clinical benefit has not been conclusively… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation; Complication, Renal Transplant
- What is being tested?
- Collection of blood and urine samples and perceived stress assessment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2027to 1 Feb 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of a prospective cohort of kidney transplant recipients followed at Nantes University Hospital over a 12-month inclusion period. The study will compare perceived stress related to the 1-year surveillance biopsy according to whether the biopsy was performed or waived based on the results of the non-invasive biomarkers used in routine clinical practice.
Who may be able to join
- Adult patients aged 18 years or older;
- Recipients of a kidney transplant from a living donor, a donor after brain death, or a donor after circulatory death;
- Patients who have provided written informed consent to participate in the ABAT study.
Who cannot join
- Pregnant or breastfeeding women;
- Patients under legal protection measures (including guardianship or curatorship);
- Patients who have undergone more than two kidney transplantations;
- Patients who have received a combined transplant or a previous transplant of another organ.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ABAT - Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
There is currently no consensus recommendation regarding the routine use of surveillance kidney allograft biopsies during the first year after transplantation. As a result, the decision to perform surveillance biopsies remains center-dependent, and their long-term clinical benefit has not been conclusively demonstrated.
Although surveillance biopsy is considered the gold standard for detecting subclinical rejection, it is an invasive and costly procedure that carries a risk of complications. Furthermore, approximately 30-35% of surveillance biopsies reveal normal or near-normal histology, highlighting the need for strategies that can safely reduce unnecessary biopsies and improve patient comfort while optimizing healthcare resource utilization.
At Nantes University Hospital, three blood and urinary biomarkers predictive of the absence of rejection are routinely used to assess the relevance of performing a surveillance biopsy. The objective of this observational study is to evaluate patients' perceived stress related to the 1-year surveillance biopsy according to whether the procedure is maintained or canceled based on the results of these non-invasive biomarkers used in standard clinical practice.
- Being tested
- Collection of blood and urine samples, perceived stress assessment
- Keywords
- Renal transplantation, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood and urine samplesBiological
Collection of blood and urine samples at 3 months for the assessment of blood and urinary biomarkers (these samples will not be used to guide the decision to perform or cancel the surveillance biopsy. They will be stored in the study biocollection for future ancillary biomarker analyses):
One PAXgene® tube (SCR score): 2.5 mL of peripheral venous blood. One Streck® Cell-Free DNA BCT tube (dd-cfDNA): 10 mL of peripheral venous blood.
One sterile urine collection tube (CXCL9/CXCL10 assay): 6 mL of fresh urine.
perceived stress assessmentOther
To assess perceived stress related to the surveillance biopsy procedure, whether guided by the biomarker-based decision algorithm or not, participants will complete a self-administered questionnaire using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 corresponds to "no stress" and 10 to "the highest level of stress imaginable."
| Study group | Role | What they receive |
|---|---|---|
| ABAT Study population | The study population will consist of a prospective cohort of kidney transplant followed at Nantes University Hospital over a 12-month inclusion period. Receives: Biological: Collection of blood and urine samples; Other: perceived stress assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress score related to the 1-year surveillance biopsy
score ranging from 0 to 10, with higher scores indicating high stress level.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplantation; ComplicationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917884
- Sponsor's protocol ID
- RC26_0150
- Other IDs
- 2026-A01329-42
- Acronym
- ABAT
- Status last verified
- Nov 2026
- First submitted
- 21 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABAT - Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
- ClinicalTrials.gov ID
- NCT07917884
- Acronym / sponsor ID
- ABAT / RC26_0150
- Keywords
- Renal transplantation, stress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 5 Nov 2026 (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.
There is currently no consensus recommendation regarding the routine use of surveillance kidney allograft biopsies during the first year after transplantation. As a result, the decision to perform surveillance biopsies remains center-dependent, and their long-term clinical benefit has not been conclusively demonstrated.
Although surveillance biopsy is considered the gold standard for detecting subclinical rejection, it is an invasive and costly procedure that carries a risk of complications. Furthermore, approximately 30-35% of surveillance biopsies reveal normal or near-normal histology, highlighting the need for strategies that can safely reduce unnecessary biopsies and improve patient comfort while optimizing healthcare resource utilization.
At Nantes University Hospital, three blood and urinary biomarkers predictive of the absence of rejection are routinely used to assess the relevance of performing a surveillance biopsy. The objective of this observational study is to evaluate patients' perceived stress related to the 1-year surveillance biopsy according to whether the procedure is maintained or canceled based on the results of these non-invasive biomarkers used in standard clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABAT Study population | – | Biological: Collection of blood and urine samples, Other: perceived stress assessmentThe study population will consist of a prospective cohort of kidney transplant followed at Nantes University Hospital over a 12-month inclusion period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of a prospective cohort of kidney transplant recipients followed at Nantes University Hospital over a 12-month inclusion period. The study will compare perceived stress related to the 1-year surveillance biopsy according to whether the biopsy was performed or waived based on the results of the non-invasive biomarkers used in routine clinical practice.
Key inclusion criteria (3 listed)
- Adult patients aged 18 years or older;
- Recipients of a kidney transplant from a living donor, a donor after brain death, or a donor after circulatory death;
- Patients who have provided written informed consent to participate in the ABAT study.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women;
- Patients under legal protection measures (including guardianship or curatorship);
- Patients who have undergone more than two kidney transplantations;
- Patients who have received a combined transplant or a previous transplant of another organ.
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 |
|---|---|---|
| Collection of blood and urine samplesCollection of blood and urine samples at 3 months for the assessment of blood and urinary biomarkers (these samples will not be used to guide the decision to perform or cancel the surveillance biopsy. They will be stored in the study biocollection for future ancillary biomarker analyses): One PAXgene® tube (SCR score): 2.5 mL of peripheral venous blood. One Streck® Cell-Free DNA BCT tube (dd-cfDNA): 10 mL of peripheral venous blood. One sterile urine collection tube (CXCL9/CXCL10 assay): 6 mL of fresh urine. | Biological | ABAT Study population |
| perceived stress assessmentTo assess perceived stress related to the surveillance biopsy procedure, whether guided by the biomarker-based decision algorithm or not, participants will complete a self-administered questionnaire using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 corresponds to "no stress" and 10 to "the highest level of stress imaginable." | Other | ABAT Study population |
Primary outcome
Perceived stress score related to the 1-year surveillance biopsy
Time frame: 12 months
score ranging from 0 to 10, with higher scores indicating high stress level.
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 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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 Transplantation; Complication and Renal Transplant, run by Nantes University Hospital 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 4 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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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?
Contact CHU Nantes département promotion (253482835 ext. +33, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress score related to the 1-year surveillance biopsy (time frame: 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 5 Nov 2026.