Kidney Transplant RejectionSRDK0921_APSNCT05747274
SRDK0921_ Analytical Performance Study
An observational study of Kidney Transplant Rejection, run by BioMAdvanced Diagnostics at 1 site in France.
Trial summary
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- SRDK0921
- Type of treatment
- Medical device
- How many people
- 439 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2023to 29 Sep 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Samples and data from patients included in the DIVAT biocollection are the leftover specimens already used in the Proof-Of-Concept study. All those specimens meet the inclusion/exclusion criteria
Who may be able to join
- Subjects that underwent kidney transplant between January 2008 and January 2016 in the following sites: University hospital center of Nantes, AP-HP Paris-Necker, and HCL Lyon.
- Subjects transplanted from living or deceased donors.
- Patients with an available paired frozen mRNA and biopsy collected at one-year post- transplantation and archived in the DIVAT bio-collection.
- Subjects with good kidney function at one-year post-transplantation (creatininemia below 160 µmol. L-1)
- Subjects under standard immunosuppressive treatments.
Who cannot join
- Subjects that underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
- Subjects that have stopped immunosuppressive treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study to Validate the Analytical Performance of an In Vitro Diagnostic (IVD) Medical Device in Patients With Kidney Transplant.
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)
Read the detailed description
It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT biocollection.
The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device (IVD).
The SRDK0921 system (kit and software) is intended:
- to calculate a score of subclinical rejection in kidney transplant patients
- as an aid in diagnosis of subclinical rejection's absence in kidney transplant recipients in conjunction with other clinical information.
- Conditions
- Kidney Transplant Rejection
- Being tested
- SRDK0921
- Keywords
- Gene expression, In Vitro Diagnostic, Subclinical rejection score, kidney allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRDK0921Device
SRDK0921 is an IVD composed of IVD kit for qPCR (SRDK0921KIT) and a cloud-based software (SRDK0921SOFT). It is a class C, rule 3k, IVD according to Regulation (EU) 2017/746.
| Study group | Role | What they receive |
|---|---|---|
| The Divat COHORT | The DIVAT cohort (Computerized and Validated Data in Transplantation) developed by the Immunology and Nephrology Department of the University Hospital of Nantes (France) , is a biocollection database linked to clinical data and plasma, serum, blood cells and urines of all kidney recipients from Nantes, Paris-Necker, and Lyon centres. The clinical and biological parameters are collected at 3 months, 6 months, 1 year and then every year.
All available specimens in the DIVAT cohort that:
* meet inclusion and exclusion criteria of this study AND
* are usable in terms of quality, integrity, and quantity. will be analysed for this study in order to maximise the power and generalisability of the results. Receives: Device: SRDK0921 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve)
To determine the analytical performance meaning the discriminating ability of the IVD (kit and software), between patients displaying a sub-clinical rejection and patients without subclinical rejection, confirmed with the gold standard method (graft biopsy). An AUC ≥ 0.75 was considered as clinically acceptable.
Measured: at 1 year after kidney transplant
Secondary outcomes (2)
Analytical sensitivity, specificity, Positive Predictive Value, Negative Predictive Value, Cut-off-value
To determine additional indicators of analytical performance of the IVD. PPV: positive predictive value NPV: negative predictive value
Measured: at 1 year after kidney transplant
Quantification of the gene expression signature
To assess the correlation level between the prior Proof-of-Concept study and this study based on the 2 genes expression signature.
Measured: at 1 year after kidney transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start21 Sep 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- 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
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMAdvanced Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nantes University Hospital
- Responsible party
- Sponsor
- Investigators
- Nicolas Bouler, Study director, BioMAdvanced Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747274
- Sponsor's protocol ID
- SRDK0921_APS
- Acronym
- SRDK0921_APS
- Status last verified
- Nov 2023
- First submitted
- 17 Feb 2023
- Last updated
- 9 Nov 2023
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Validate the Analytical Performance of an In Vitro Diagnostic (IVD) Medical Device in Patients With Kidney Transplant.
- ClinicalTrials.gov ID
- NCT05747274
- Acronym / sponsor ID
- SRDK0921_APS / SRDK0921_APS
- Conditions
- Kidney Transplant Rejection
- Keywords
- Gene expression, In Vitro Diagnostic, Subclinical rejection score, kidney allograft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- BioMAdvanced DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Nantes University Hospital
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 28 Feb 2023 (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.
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)
Detailed description
It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT biocollection.
The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device (IVD).
The SRDK0921 system (kit and software) is intended:
- to calculate a score of subclinical rejection in kidney transplant patients
- as an aid in diagnosis of subclinical rejection's absence in kidney transplant recipients in conjunction with other clinical information.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Divat COHORT | – | Device: SRDK0921The DIVAT cohort (Computerized and Validated Data in Transplantation) developed by the Immunology and Nephrology Department of the University Hospital of Nantes (France) , is a biocollection database linked to clinical data and plasma, serum, blood cells and urines of all kidney recipients from Nantes, Paris-Necker, and Lyon centres. The clinical and biological parameters are collected at 3 months, 6 months, 1 year and then every year. All available specimens in the DIVAT cohort that: * meet inclusion and exclusion criteria of this study AND * are usable in terms of quality, integrity, and quantity. will be analysed for this study in order to maximise the power and generalisability of the results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples and data from patients included in the DIVAT biocollection are the leftover specimens already used in the Proof-Of-Concept study. All those specimens meet the inclusion/exclusion criteria
Key inclusion criteria (5 listed)
- Subjects that underwent kidney transplant between January 2008 and January 2016 in the following sites: University hospital center of Nantes, AP-HP Paris-Necker, and HCL Lyon.
- Subjects transplanted from living or deceased donors.
- Patients with an available paired frozen mRNA and biopsy collected at one-year post- transplantation and archived in the DIVAT bio-collection.
- Subjects with good kidney function at one-year post-transplantation (creatininemia below 160 µmol. L-1)
- Subjects under standard immunosuppressive treatments.
Key exclusion criteria (2 listed)
- Subjects that underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
- Subjects that have stopped immunosuppressive treatments.
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 |
|---|---|---|
| SRDK0921SRDK0921 is an IVD composed of IVD kit for qPCR (SRDK0921KIT) and a cloud-based software (SRDK0921SOFT). It is a class C, rule 3k, IVD according to Regulation (EU) 2017/746. | Device | The Divat COHORT |
Primary outcome
AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve)
Time frame: at 1 year after kidney transplant
To determine the analytical performance meaning the discriminating ability of the IVD (kit and software), between patients displaying a sub-clinical rejection and patients without subclinical rejection, confirmed with the gold standard method (graft biopsy). An AUC ≥ 0.75 was considered as clinically acceptable.
2 secondary outcomes
Analytical sensitivity, specificity, Positive Predictive Value, Negative Predictive Value, Cut-off-value
Time frame: at 1 year after kidney transplant
Quantification of the gene expression signature
Time frame: at 1 year after kidney transplant
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 9 Nov 2023.
- 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. This study is not recruiting at the moment.
Nicolas Bouler study director
BioMAdvanced Diagnostics
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 Kidney Transplant Rejection, run by BioMAdvanced Diagnostics 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 5 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: finished, as of the sponsor's last update on 9 Nov 2023. 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?
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?
AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve) (time frame: at 1 year after kidney transplant). 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 9 Nov 2023.