Kidney Rejection TransplantNCT07091214
Molecular Transcriptomics in Diagnosing Pediatric Kidney Transplant Rejection: the PANDA-Kids-ATLAS Study
An observational study of Kidney Rejection Transplant, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.
Trial summary
Children with kidney failure have markedly increased mortality and face repeated transplantation over their lifetime due to limited allograft half-life (12-15 years). Current biopsy-based diagnoses of rejection (using Banff 2022 criteria) suffer from variability and limited sensitivity. Read more about this study
- Who is it for?
- Ages 0 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Rejection Transplant
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 31 Dec 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 0 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric kidney transplant recipients
Who may be able to join
- Age ≤ 21 years
- Single kidney transplant recipients (deceased or living donor)
- Written informed consent from patients/guardians
Who cannot join
- Multi-organ transplantation history
- Biopsies with insufficient tissue
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
Paris Institute for Transplantation and Organ Regeneration (PITOR)
Paris, 75015
About this study
Official title: Precision Allograft Rejection Using Novel Diagnostic Approaches in Kidney Transplantation - Allograft Transcriptomics Landscape Analysis Using Sequencing (the PANDA-Kids-ATLAS Study)
Children with kidney failure have markedly increased mortality and face repeated transplantation over their lifetime due to limited allograft half-life (12-15 years). Current biopsy-based diagnoses of rejection (using Banff 2022 criteria) suffer from variability and limited sensitivity. PANDA-Kids-ATLAS will analyze up to 600 pediatric FFPE kidney biopsies across multiple centres using the Banff Human Organ Transplant (B-HOT) NanoString panel to develop and validate molecular classifiers of AMR, TCMR and related phenotypes. A secure REDCap database will integrate molecular, pathological and clinical data, aiming to improve early detection, personalize therapy, and enhance long-term graft survival and patient quality of life.
Read the detailed description
The study builds a deeply phenotyped international cohort of pediatric transplant patients (<21 years) with both retrospective (2014-present) and prospective (through Dec 2027) biopsy sampling. Four diagnostic "baskets" (classical AMR/TCMR; probable ABMR/MVI; other injury; normal) will each contribute equal numbers of cases for classifier validation (Part A) and real-world prevalence samples for outcome association (Part B). FFPE blocks will be centrally reviewed via Banff 2022 automated and expert pathologist interpretation, then processed by NanoString nCounter® using the 770-gene B-HOT panel. Stratified random sampling, robust QC, and integration with clinical/immunological parameters in REDCap will underpin molecular classifier development and validation. Follow-up includes clinical outcomes and graft function monitoring.
- Conditions
- Kidney Rejection Transplant
- Keywords
- transcriptomics, pediatric kidney transplantation, allograft rejection, precision diagnosis, molecular classifiers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Classic rejection profile | Active/chronic AMR or TCMR | |
| Group 2: Other rejection profiles | Probable AMR, MVI+DSA- C4d-, borderline or mixed rejection | |
| Group 3: Other diagnoses | CMV, CNI toxicity, recurrence, BK nephropathy | |
| Group 4: Normal biopsies | No lesions (normal biopsy results) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Molecular Classifiers for Kidney Allograft Rejection Using Banff Human Organ Transplant (B-HOT) Gene Panel via NanoString nCounter®
Molecular signatures (molecular classifiers) will be identified through bulk transcriptomic analysis utilizing the validated Banff Human Organ Transplant (B-HOT) gene panel, consisting of 770 rejection- and tolerance-related genes. Formalin-fixed, paraffin-embedded (FFPE) biopsy samples from pediatric kidney transplant recipients will be processed and analyzed using the NanoString nCounter® platform. Specifically, molecular classifiers distinguishing classical antibody-mediated rejection (AMR), T-cell mediated rejection (TCMR), and novel Banff 2022 antibody-mediated rejection-related categories-including microvascular inflammation with donor-specific antibodies and negative C4d staining (MVI+DSA-C4d-) and probable antibody-mediated rejection (pABMR)-will be quantified and reported. Classifier results will be summarized as normalized gene expression profiles, enabling clear discrimination among different categories of rejection and non-rejection biopsies.
Measured: 3 years
Secondary outcomes (2)
Integration of Molecular Classifiers with Clinical Parameters into an Archetype-based Diagnostic System for Kidney Allograft Rejection
An archetype-based diagnostic framework will be generated by integrating transcriptomic molecular classifiers (quantified using NanoString nCounter® platform and Banff Human Organ Transplant (B-HOT) gene panel) with clinical parameters. Clinical parameters include patient demographics (age, sex), transplant characteristics, and clinical outcomes (e.g., serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria, biopsy indication). The integrated diagnostic system will provide archetype-based patient profiles to enhance diagnostic precision and personalized clinical management. Aggregation will be performed using multidimensional modeling techniques (principal component analysis, cluster analyses) and classification algorithms (logistic regression, random forest), providing composite diagnostic archetypes.
Unit of measure: Composite diagnostic archetype (multidimensional categorical profile)
Measured: 3 years
Integration of Molecular Classifiers with Biological and Immunological Parameters into an Archetype-based Diagnostic System for Kidney Allograft Rejection
An archetype-based multidimensional diagnostic framework will be developed by combining transcriptomic molecular classifiers (from the NanoString nCounter® platform and B-HOT gene panel) with biological and immunological parameters. Specifically, this will include immunological markers such as donor-specific antibodies (DSA), C4d staining, complement factors, and inflammatory biomarkers (e.g., cytokines, chemokines, immune cell subset analysis). The integration will be conducted through bioinformatics approaches and supervised machine learning models, culminating in archetypal patient classification based on immune and biological profiles.
Unit of measure: Composite immuno-biological archetype (multidimensional categorical profile)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney Rejection TransplantStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Collaborators
- Paris Cardiovascular Research Center (Inserm U970)
- Responsible party
- Sponsor
- Investigators
- Evgenia Preka, MD, PhDc, Principal investigator, INSERM U970Alexandre Loupy, MD, PhD, Study chair, INSERM U970Valentin Goutaudier, MD, PhD, Study chair, INSERM U970
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091214
- Sponsor's protocol ID
- Transcriptomics_PED_001
- Status last verified
- Jul 2025
- First submitted
- 22 May 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: molecular classifiers results
Publications
Sablik M, Sannier A, Raynaud M, Goutaudier V, Divard G, Astor BC, Weng P, Smith J, Garro R, Warady BA, Zahr RS, Twombley K, Dharnidharka VR, Dandamudi RS, Fila M, Huang E, Sellier-Leclerc AL, Tonshoff B, Rabant M, Verine J, Del Bello A, Berney T, Boyer O, Catar RA, Danger R, Giral M, Yoo D, Girardin FR, Alsadi A, Gourraud PA, Morelon E, Le Quintrec M, Try M, Villard J, Zhong W, Bestard O, Budde K, Chauveau B, Couzi L, Brouard S, Hogan J, Legendre C, Anglicheau D, Aubert O, Kamar N, Lefaucheur C, Loupy A. Microvascular Inflammation of Kidney Allografts and Clinical Outcomes. N Engl J Med. 2025 Feb 20;392(8):763-776. doi: 10.1056/NEJMoa2408835. Epub 2024 Oct 24.
PubMed 39450752Halloran PF, Madill-Thomsen KS, Bohmig G, Bromberg J, Budde K, Barner M, Mackova M, Chang J, Einecke G, Eskandary F, Gupta G, Myslak M, Viklicky O, Akalin E, Alhamad T, Anand S, Arnol M, Baliga R, Banasik M, Bingaman A, Blosser CD, Brennan D, Chamienia A, Chow K, Ciszek M, de Freitas D, Deborska-Materkowska D, Debska-Slizien A, Djamali A, Domanski L, Durlik M, Fatica R, Francis I, Fryc J, Gill J, Gill J, Glyda M, Gourishankar S, Grenda R, Gryczman M, Hruba P, Hughes P, Jittirat A, Jurekovic Z, Kamal L, Kamel M, Kant S, Kasiske B, Kojc N, Konopa J, Lan J, Mannon R, Matas A, Mazurkiewicz J, Miglinas M, Muller T, Narins S, Naumnik B, Patel A, Perkowska-Ptasinska A, Picton M, Piecha G, Poggio E, Bloudickova SR, Samaniego-Picota M, Schachtner T, Shin S, Shojai S, Sikosana MLN, Slatinska J, Smykal-Jankowiak K, Solanki A, Veceric Haler Z, Vucur K, Weir MR, Wiecek A, Wlodarczyk Z, Yang H, Zaky Z. Subthreshold rejection activity in many kidney transplants currently classified as having no rejection. Am J Transplant. 2025 Jan;25(1):72-87. doi: 10.1016/j.ajt.2024.07.034. Epub 2024 Aug 6.
PubMed 39117038Mengel M, Loupy A, Haas M, Roufosse C, Naesens M, Akalin E, Clahsen-van Groningen MC, Dagobert J, Demetris AJ, Duong van Huyen JP, Gueguen J, Issa F, Robin B, Rosales I, Von der Thusen JH, Sanchez-Fueyo A, Smith RN, Wood K, Adam B, Colvin RB. Banff 2019 Meeting Report: Molecular diagnostics in solid organ transplantation-Consensus for the Banff Human Organ Transplant (B-HOT) gene panel and open source multicenter validation. Am J Transplant. 2020 Sep;20(9):2305-2317. doi: 10.1111/ajt.16059. Epub 2020 Jun 27.
PubMed 32428337Zielinski D, Goutaudier V, Sablik M, Divard G, Aubert O, Piedrafita A, Mezine F, Dagobert J, Certain A, Robin B, Gueguen J, Rabant M, Duong van Huyen JP, Sannier A, Randoux-Lebrun C, Maanaoui M, Lionet A, Gibier JB, Gnemmi V, Le Quintrec M, Chauveau B, Vermorel A, Couzi L, Bestard O, Elias M, Louis K, Rosales IA, Smith RN, Kung VL, Anglicheau D, Legendre C, Del Bello A, Huang E, Adam B, Kamar N, Colvin RB, Mengel M, Lefaucheur C, Loupy A. Molecular diagnosis of kidney allograft rejection based on the Banff Human Organ Transplant gene panel: A multicenter international study. Am J Transplant. 2025 Aug;25(8):1631-1642. doi: 10.1016/j.ajt.2025.04.025. Epub 2025 May 8.
PubMed 40345499Fichtner A, Gauche L, Susal C, Tran TH, Waldherr R, Krupka K, Guzzo I, Carraro A, Oh J, Zirngibl M, Weitz M, Konig J, Buscher A, Berta L, Simon T, Awan A, Rusai K, Topaloglu R, Peruzzi L, Printza N, Kim JJ, Weber LT, Melk A, Pape L, Rieger S, Patry C, Hocker B, Tonshoff B; CERTAIN study group. Incidence, risk factors, management strategies, and outcomes of antibody-mediated rejection in pediatric kidney transplant recipients-a multicenter analysis of the Cooperative European Paediatric Renal Transplant Initiative (CERTAIN). Pediatr Nephrol. 2025 Feb;40(2):491-503. doi: 10.1007/s00467-024-06487-2. Epub 2024 Sep 16.
PubMed 39283519
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Allograft Rejection Using Novel Diagnostic Approaches in Kidney Transplantation - Allograft Transcriptomics Landscape Analysis Using Sequencing (the PANDA-Kids-ATLAS Study)
- ClinicalTrials.gov ID
- NCT07091214
- Acronym / sponsor ID
- Transcriptomics_PED_001
- Conditions
- Kidney Rejection Transplant
- Keywords
- transcriptomics, pediatric kidney transplantation, allograft rejection, precision diagnosis, molecular classifiers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Collaborators
- Paris Cardiovascular Research Center (Inserm U970)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jul 2025 (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.
Children with kidney failure have markedly increased mortality and face repeated transplantation over their lifetime due to limited allograft half-life (12-15 years). Current biopsy-based diagnoses of rejection (using Banff 2022 criteria) suffer from variability and limited sensitivity. PANDA-Kids-ATLAS will analyze up to 600 pediatric FFPE kidney biopsies across multiple centres using the Banff Human Organ Transplant (B-HOT) NanoString panel to develop and validate molecular classifiers of AMR, TCMR and related phenotypes. A secure REDCap database will integrate molecular, pathological and clinical data, aiming to improve early detection, personalize therapy, and enhance long-term graft survival and patient quality of life.
Detailed description
The study builds a deeply phenotyped international cohort of pediatric transplant patients (<21 years) with both retrospective (2014-present) and prospective (through Dec 2027) biopsy sampling. Four diagnostic "baskets" (classical AMR/TCMR; probable ABMR/MVI; other injury; normal) will each contribute equal numbers of cases for classifier validation (Part A) and real-world prevalence samples for outcome association (Part B). FFPE blocks will be centrally reviewed via Banff 2022 automated and expert pathologist interpretation, then processed by NanoString nCounter® using the 770-gene B-HOT panel. Stratified random sampling, robust QC, and integration with clinical/immunological parameters in REDCap will underpin molecular classifier development and validation. Follow-up includes clinical outcomes and graft function monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Classic rejection profile | – | –Active/chronic AMR or TCMR |
| Group 2: Other rejection profiles | – | –Probable AMR, MVI+DSA- C4d-, borderline or mixed rejection |
| Group 3: Other diagnoses | – | –CMV, CNI toxicity, recurrence, BK nephropathy |
| Group 4: Normal biopsies | – | –No lesions (normal biopsy results) |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric kidney transplant recipients
Key inclusion criteria (3 listed)
- Age ≤ 21 years
- Single kidney transplant recipients (deceased or living donor)
- Written informed consent from patients/guardians
Key exclusion criteria (2 listed)
- Multi-organ transplantation history
- Biopsies with insufficient tissue
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
Identification of Molecular Classifiers for Kidney Allograft Rejection Using Banff Human Organ Transplant (B-HOT) Gene Panel via NanoString nCounter®
Time frame: 3 years
Molecular signatures (molecular classifiers) will be identified through bulk transcriptomic analysis utilizing the validated Banff Human Organ Transplant (B-HOT) gene panel, consisting of 770 rejection- and tolerance-related genes. Formalin-fixed, paraffin-embedded (FFPE) biopsy samples from pediatric kidney transplant recipients will be processed and analyzed using the NanoString nCounter® platform. Specifically, molecular classifiers distinguishing classical antibody-mediated rejection (AMR), T-cell mediated rejection (TCMR), and novel Banff 2022 antibody-mediated rejection-related categories-including microvascular inflammation with donor-specific antibodies and negative C4d staining (MVI+DSA-C4d-) and probable antibody-mediated rejection (pABMR)-will be quantified and reported. Classifier results will be summarized as normalized gene expression profiles, enabling clear discrimination among different categories of rejection and non-rejection biopsies.
2 secondary outcomes
Integration of Molecular Classifiers with Clinical Parameters into an Archetype-based Diagnostic System for Kidney Allograft Rejection
Time frame: 3 years
Integration of Molecular Classifiers with Biological and Immunological Parameters into an Archetype-based Diagnostic System for Kidney Allograft Rejection
Time frame: 3 years
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 29 Jul 2025.
- Background: PubMed 39450752Sablik M, Sannier A, Raynaud M, Goutaudier V, Divard G, Astor BC, Weng P, Smith J, Garro R, Warady BA, Zahr RS, Twombley K, Dharnidharka VR, Dandamudi RS, Fila M, Huang E, Sellier-Leclerc AL, Tonshoff B, Rabant M, Verine J, Del Bello A, Berney T, Boyer O, Catar RA, Danger R, Giral M, Yoo D, Girardin FR, Alsadi A, Gourraud PA, Morelon E, Le Quintrec M, Try M, Villard J, Zhong W, Bestard O, Budde K, Chauveau B, Couzi L, Brouard S, Hogan J, Legendre C, Anglicheau D, Aubert O, Kamar N, Lefaucheur C, Loupy A. Microvascular Inflammation of Kidney Allografts and Clinical Outcomes. N Engl J Med. 2025 Feb 20;392(8):763-776. doi: 10.1056/NEJMoa2408835. Epub 2024 Oct 24.
- Background: PubMed 39117038Halloran PF, Madill-Thomsen KS, Bohmig G, Bromberg J, Budde K, Barner M, Mackova M, Chang J, Einecke G, Eskandary F, Gupta G, Myslak M, Viklicky O, Akalin E, Alhamad T, Anand S, Arnol M, Baliga R, Banasik M, Bingaman A, Blosser CD, Brennan D, Chamienia A, Chow K, Ciszek M, de Freitas D, Deborska-Materkowska D, Debska-Slizien A, Djamali A, Domanski L, Durlik M, Fatica R, Francis I, Fryc J, Gill J, Gill J, Glyda M, Gourishankar S, Grenda R, Gryczman M, Hruba P, Hughes P, Jittirat A, Jurekovic Z, Kamal L, Kamel M, Kant S, Kasiske B, Kojc N, Konopa J, Lan J, Mannon R, Matas A, Mazurkiewicz J, Miglinas M, Muller T, Narins S, Naumnik B, Patel A, Perkowska-Ptasinska A, Picton M, Piecha G, Poggio E, Bloudickova SR, Samaniego-Picota M, Schachtner T, Shin S, Shojai S, Sikosana MLN, Slatinska J, Smykal-Jankowiak K, Solanki A, Veceric Haler Z, Vucur K, Weir MR, Wiecek A, Wlodarczyk Z, Yang H, Zaky Z. Subthreshold rejection activity in many kidney transplants currently classified as having no rejection. Am J Transplant. 2025 Jan;25(1):72-87. doi: 10.1016/j.ajt.2024.07.034. Epub 2024 Aug 6.
- Background: PubMed 32428337Mengel M, Loupy A, Haas M, Roufosse C, Naesens M, Akalin E, Clahsen-van Groningen MC, Dagobert J, Demetris AJ, Duong van Huyen JP, Gueguen J, Issa F, Robin B, Rosales I, Von der Thusen JH, Sanchez-Fueyo A, Smith RN, Wood K, Adam B, Colvin RB. Banff 2019 Meeting Report: Molecular diagnostics in solid organ transplantation-Consensus for the Banff Human Organ Transplant (B-HOT) gene panel and open source multicenter validation. Am J Transplant. 2020 Sep;20(9):2305-2317. doi: 10.1111/ajt.16059. Epub 2020 Jun 27.
- Background: PubMed 40345499Zielinski D, Goutaudier V, Sablik M, Divard G, Aubert O, Piedrafita A, Mezine F, Dagobert J, Certain A, Robin B, Gueguen J, Rabant M, Duong van Huyen JP, Sannier A, Randoux-Lebrun C, Maanaoui M, Lionet A, Gibier JB, Gnemmi V, Le Quintrec M, Chauveau B, Vermorel A, Couzi L, Bestard O, Elias M, Louis K, Rosales IA, Smith RN, Kung VL, Anglicheau D, Legendre C, Del Bello A, Huang E, Adam B, Kamar N, Colvin RB, Mengel M, Lefaucheur C, Loupy A. Molecular diagnosis of kidney allograft rejection based on the Banff Human Organ Transplant gene panel: A multicenter international study. Am J Transplant. 2025 Aug;25(8):1631-1642. doi: 10.1016/j.ajt.2025.04.025. Epub 2025 May 8.
- Background: PubMed 39283519Fichtner A, Gauche L, Susal C, Tran TH, Waldherr R, Krupka K, Guzzo I, Carraro A, Oh J, Zirngibl M, Weitz M, Konig J, Buscher A, Berta L, Simon T, Awan A, Rusai K, Topaloglu R, Peruzzi L, Printza N, Kim JJ, Weber LT, Melk A, Pape L, Rieger S, Patry C, Hocker B, Tonshoff B; CERTAIN study group. Incidence, risk factors, management strategies, and outcomes of antibody-mediated rejection in pediatric kidney transplant recipients-a multicenter analysis of the Cooperative European Paediatric Renal Transplant Initiative (CERTAIN). Pediatr Nephrol. 2025 Feb;40(2):491-503. doi: 10.1007/s00467-024-06487-2. Epub 2024 Sep 16.
- CERTAIN registry protocol for participating centers via CERTAINLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. molecular classifiers results
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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.
Evgenia Preka, MD, PhDc principal investigator
INSERM U970
Alexandre Loupy, MD, PhD study chair
INSERM U970
Valentin Goutaudier, MD, PhD study chair
INSERM U970
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 Rejection Transplant, run by Paris Translational Research Center for Organ Transplantation 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: opening soon, as of the sponsor's last update on 29 Jul 2025. 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 Evgenia Preka, MD, PhDc (+33 1 44 23 60 00, evgenia.preka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Molecular Classifiers for Kidney Allograft Rejection Using Banff Human Organ Transplant (B-HOT) Gene Panel via NanoString nCounter® (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07091214, which also lists 5 linked publications.
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 29 Jul 2025.