Validation Study of Molecular Diagnostic SystemNCT01299168
Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
An observational study of Validation Study of Molecular Diagnostic System and Development of Reporting System for Molecular Diagnosis, run by University of Alberta at 26 sites in 14 countries.
Trial summary
The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validation Study of Molecular Diagnostic System, Development of Reporting System for Molecular Diagnosis, Incorporate Molecular Diagnosis Into Diagnostic Standards
- How many people
- 500 participants
- Where
- 26 sitesin 14 countries
- Study dates
- May 2011to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinicalindications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria).
Who may be able to join
- All kidney transplant recipients ≥18yrs of age undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enrol in the study.
Who cannot join
- Patients will be excluded from the study if they decline participation or are unable to give informed consent.
Trial locations and contacts
26 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 14 countries
United States10 sites
- Completed
University of Michigan Health System
Ann Arbor, Michigan, 48109-5395
- Completed
University of Maryland School of Medicine
Baltimore, Maryland, 21209
- Completed
University of Alabama
Birmingham, Alabama, 35294-0006
- Completed
Pinnacle Transplant Associates
Harrisburg, Pennsylvania
- Completed
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, WI 53705
- Completed
University of Minnesota
Minneapolis, Minnesota, 55455
- Completed
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
- Completed
Texas Transplant Institute - Methodist Healthcare System
San Antonio, Texas, 78229
- Completed
Barnes-Jewish Hospital
St Louis, Missouri, 63110
- Completed
Montefiore Medical Center
The Bronx, New York
Canada2 sites, 1 recruiting
- Recruiting
Department of Medicine, University of Alberta
Edmonton, Alberta, T6G 2S2
Soroush Shojai, MD, shojai@ualberta.ca
Soroush Shojai, MD
- Withdrawn
University of British Columbia, St. Paul's Hospital
Vancouver, British Columbia
Germany2 sites
- Completed
Charité - Universitätmedizin Berlin
Berlin
- Completed
Medizinische Hochschule
Hanover, 30625
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Georg Boehmig, MD PhD, georg.boehmig@meduniwien.ac.at
Farsad Eskandry, MD, farsad.eskandary@meduniwien.ac.at
Czechia1 site, 1 recruiting
- Recruiting
Institute for Experimental and Clinical Medicine (IKEM)
Prague
Petra Hruba, Dr, hrup@ikem.cz
Ondrej Viklicky, Dr
South Korea1 site
- Completed
Department of Surgery, University of Usan, College of Medicine
Seoul, 05505
United Kingdom1 site
- Completed
Manchester Royal Infirmary
Manchester, M13 9WL
About this study
Official title: Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies
The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from American, Canadian and European centres in addition to 300 biopsies already collected. Due to a considerable interest and support from participating Centers, the study is further extended to 1500 prospective biopsies. Thus this is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the feasibility and value of this System in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.
Read the detailed description
The study has enrolled so far 3012 biopsies from 2313 participants and the results are analyzed for these biopsies. Follow-up data is, and will be collected.
- Conditions
- Validation Study of Molecular Diagnostic System, Development of Reporting System for Molecular Diagnosis, Incorporate Molecular Diagnosis Into Diagnostic Standards
- Keywords
- global gene expression, molecular diagnostic 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 |
|---|---|---|
| Kidney Transplant Biopsies for Cause | The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study
- The rejection classifier predicts Banff diagnosis of any rejection: ABMR, TCMR, or mixed ABMR and TCMR;
- The TCMR classifier predicts the presence of Banff TCMR lesions/diagnoses;
- The ABMR classifier predicts the presence of ABMR lesions;
- In late (>1yr) biopsies for clinical indications, the failure classifier predicts failure within three years.
Measured: 2013-2016
Secondary outcomes (2)
Demonstrate the feasibility of molecular phenotyping of 300 + 500 kidney transplant biopsies for clinical indications.
To test the hypothesis that the molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample.
Measured: 2014-2016
Demonstrate the feasibility of molecular phenotyping of 500 biopsies in real time i.e. returning the molecular phenotyping report in two working days upon sample arrival.
Refine the reports based on feedback from the participants.
Measured: 2015-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Validation Study of Molecular Diagnostic SystemStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Halloran, University of Alberta
- Investigators
- Philip F Halloran, MD PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299168
- Sponsor's protocol ID
- ATAGC-001
- Status last verified
- Jun 2026
- First submitted
- 16 Feb 2011
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Halloran PF, Famulski KS, Reeve J. Molecular assessment of disease states in kidney transplant biopsy samples. Nat Rev Nephrol. 2016 Sep;12(9):534-48. doi: 10.1038/nrneph.2016.85. Epub 2016 Jun 27.
PubMed 27345248Halloran PF, Venner JM, Famulski KS. Comprehensive Analysis of Transcript Changes Associated With Allograft Rejection: Combining Universal and Selective Features. Am J Transplant. 2017 Jul;17(7):1754-1769. doi: 10.1111/ajt.14200. Epub 2017 Feb 25.
PubMed 28101959Halloran PF, Madill-Thomsen KS, Reeve J. The Molecular Phenotype of Kidney Transplants: Insights From the MMDx Project. Transplantation. 2024 Jan 1;108(1):45-71. doi: 10.1097/TP.0000000000004624. Epub 2023 Dec 13.
PubMed 37310258Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.
PubMed 38819301Halloran PF, Chang J, Mackova M, Madill-Thomsen KS, Akalin E, Alhamad T, Anand S, Arnol M, Baliga R, Banasik M, Blosser CD, Bohmig G, Brennan D, Bromberg J, Budde K, Chamienia A, Chow K, Ciszek M, de Freitas D, Deborska-Materkowska D, Debska-Slizien A, Djamali A, Domanski L, Durlik M, Einecke G, Eskandary F, Fatica R, Francis I, Fryc J, Gill J, Gill J, Glyda M, Gourishankar S, Gryczman M, Gupta G, Hruba P, Hughes P, Jittirat A, Jurekovic Z, Kamal L, Kamel M, Kant S, Kojc N, Konopa J, Lan J, Mannon RB, Matas A, Mazurkiewicz J, Miglinas M, Mueller T, Myslak M, Narins S, Naumnik B, Patel A, Perkowska-Ptasinska A, Picton M, Piecha G, Poggio E, Rajnochova Bloudickova S, Schachtner T, Shojai S, Sikosana ML, Slatinska J, Smykal-Jankowiak K, Solanki A, Veceric Haler Z, Viklicky O, Vucur K, Weir MR, Wiecek A, Wlodarczyk Z, Yang H, Zaky Z, Gauthier PT, Hinze C. A cross-sectional study of the role of epithelial cell injury in kidney transplant outcomes. JCI Insight. 2025 Apr 15;10(10):e188658. doi: 10.1172/jci.insight.188658. eCollection 2025 May 22.
PubMed 40232852Diebold M, Gauthier PT, Mayer KA, Mackova M, Hinze C, Chang J, Patel UD, Schutz E, Jilma B, Schrezenmeier E, Budde K, Bohmig GA, Halloran PF. Effect of felzartamab on the molecular phenotype of antibody-mediated rejection in kidney transplant biopsies. Nat Med. 2025 May;31(5):1668-1676. doi: 10.1038/s41591-025-03653-3. Epub 2025 Apr 29.
PubMed 40301559Callemeyn J, Nava-Sedeno JM, Anglicheau D, Beadle J, Brasen JH, Clahsen-van Groningen MC, Cristoferi I, de Loor H, Deutsch A, Essig M, Gwinner W, Halloran PF, Hesselink DA, Koshy P, Kuypers D, Lerut E, Marquet P, Minnee RC, Roufosse C, Sprangers B, Van Craenenbroeck AH, Hatzikirou H, Naesens M. Identification and Cross-Platform Validation of Sparse Molecular Classifiers for Antibody-Mediated and T-Cell-Mediated Rejection After Kidney Transplantation. Kidney Int Rep. 2025 Apr 1;10(6):1806-1818. doi: 10.1016/j.ekir.2025.03.048. eCollection 2025 Jun.
PubMed 40630324Halloran PF, Pereira AB, Chang J, Matas A, Picton M, De Freitas D, Bromberg J, Seron D, Sellares J, Einecke G, Reeve J. Potential impact of microarray diagnosis of T cell-mediated rejection in kidney transplants: The INTERCOM study. Am J Transplant. 2013 Sep;13(9):2352-63. doi: 10.1111/ajt.12387. Epub 2013 Aug 5.
PubMed 23915426Halloran PF, Pereira AB, Chang J, Matas A, Picton M, De Freitas D, Bromberg J, Seron D, Sellares J, Einecke G, Reeve J. Microarray diagnosis of antibody-mediated rejection in kidney transplant biopsies: an international prospective study (INTERCOM). Am J Transplant. 2013 Nov;13(11):2865-74. doi: 10.1111/ajt.12465. Epub 2013 Oct 3.
PubMed 24119109Loupy A, Lefaucheur C, Vernerey D, Chang J, Hidalgo LG, Beuscart T, Verine J, Aubert O, Dubleumortier S, Duong van Huyen JP, Jouven X, Glotz D, Legendre C, Halloran PF. Molecular microscope strategy to improve risk stratification in early antibody-mediated kidney allograft rejection. J Am Soc Nephrol. 2014 Oct;25(10):2267-77. doi: 10.1681/ASN.2013111149. Epub 2014 Apr 3.
PubMed 24700874Halloran PF, Chang J, Famulski K, Hidalgo LG, Salazar ID, Merino Lopez M, Matas A, Picton M, de Freitas D, Bromberg J, Seron D, Sellares J, Einecke G, Reeve J. Disappearance of T Cell-Mediated Rejection Despite Continued Antibody-Mediated Rejection in Late Kidney Transplant Recipients. J Am Soc Nephrol. 2015 Jul;26(7):1711-20. doi: 10.1681/ASN.2014060588. Epub 2014 Nov 6.
PubMed 25377077Halloran PF, Merino Lopez M, Barreto Pereira A. Identifying Subphenotypes of Antibody-Mediated Rejection in Kidney Transplants. Am J Transplant. 2016 Mar;16(3):908-20. doi: 10.1111/ajt.13551. Epub 2016 Jan 6.
PubMed 26743766Reeve J, Chang J, Salazar ID, Lopez MM, Halloran PF. Using Molecular Phenotyping to Guide Improvements in the Histologic Diagnosis of T Cell-Mediated Rejection. Am J Transplant. 2016 Apr;16(4):1183-92. doi: 10.1111/ajt.13572. Epub 2016 Jan 5.
PubMed 26730747Eskandary F, Bond G, Kozakowski N, Regele H, Marinova L, Wahrmann M, Kikic Z, Haslacher H, Rasoul-Rockenschaub S, Kaltenecker CC, Konig F, Hidalgo LG, Oberbauer R, Halloran PF, Bohmig GA. Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection-Results of a Cross-Sectional Screening Study. Transplantation. 2017 Mar;101(3):631-641. doi: 10.1097/TP.0000000000001195.
PubMed 27120452Aubert O, Loupy A, Hidalgo L, Duong van Huyen JP, Higgins S, Viglietti D, Jouven X, Glotz D, Legendre C, Lefaucheur C, Halloran PF. Antibody-Mediated Rejection Due to Preexisting versus De Novo Donor-Specific Antibodies in Kidney Allograft Recipients. J Am Soc Nephrol. 2017 Jun;28(6):1912-1923. doi: 10.1681/ASN.2016070797. Epub 2017 Mar 2.
PubMed 28255002
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies
- ClinicalTrials.gov ID
- NCT01299168
- Acronym / sponsor ID
- ATAGC-001
- Conditions
- Validation Study of Molecular Diagnostic System, Development of Reporting System for Molecular Diagnosis, Incorporate Molecular Diagnosis Into Diagnostic Standards
- Keywords
- global gene expression, molecular diagnostic classifiers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Feb 2011 (estimated)
- 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.
The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from American, Canadian and European centres in addition to 300 biopsies already collected. Due to a considerable interest and support from participating Centers, the study is further extended to 1500 prospective biopsies. Thus this is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the feasibility and value of this System in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.
Detailed description
The study has enrolled so far 3012 biopsies from 2313 participants and the results are analyzed for these biopsies. Follow-up data is, and will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplant Biopsies for Cause | – | –The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinicalindications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria).
Key inclusion criteria (1 listed)
- All kidney transplant recipients ≥18yrs of age undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enrol in the study.
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if they decline participation or are unable to give informed consent.
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
Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study
Time frame: 2013-2016
1. The rejection classifier predicts Banff diagnosis of any rejection: ABMR, TCMR, or mixed ABMR and TCMR; 2. The TCMR classifier predicts the presence of Banff TCMR lesions/diagnoses; 3. The ABMR classifier predicts the presence of ABMR lesions; 4. In late (>1yr) biopsies for clinical indications, the failure classifier predicts failure within three years.
2 secondary outcomes
Demonstrate the feasibility of molecular phenotyping of 300 + 500 kidney transplant biopsies for clinical indications.
Time frame: 2014-2016
Demonstrate the feasibility of molecular phenotyping of 500 biopsies in real time i.e. returning the molecular phenotyping report in two working days upon sample arrival.
Time frame: 2015-2016
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 2 Jun 2026.
- Background: PubMed 27345248Halloran PF, Famulski KS, Reeve J. Molecular assessment of disease states in kidney transplant biopsy samples. Nat Rev Nephrol. 2016 Sep;12(9):534-48. doi: 10.1038/nrneph.2016.85. Epub 2016 Jun 27.
- Background: PubMed 28101959Halloran PF, Venner JM, Famulski KS. Comprehensive Analysis of Transcript Changes Associated With Allograft Rejection: Combining Universal and Selective Features. Am J Transplant. 2017 Jul;17(7):1754-1769. doi: 10.1111/ajt.14200. Epub 2017 Feb 25.
- Background: PubMed 37310258Halloran PF, Madill-Thomsen KS, Reeve J. The Molecular Phenotype of Kidney Transplants: Insights From the MMDx Project. Transplantation. 2024 Jan 1;108(1):45-71. doi: 10.1097/TP.0000000000004624. Epub 2023 Dec 13.
- Background: PubMed 38819301Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.
- Background: PubMed 40232852Halloran PF, Chang J, Mackova M, Madill-Thomsen KS, Akalin E, Alhamad T, Anand S, Arnol M, Baliga R, Banasik M, Blosser CD, Bohmig G, Brennan D, Bromberg J, Budde K, Chamienia A, Chow K, Ciszek M, de Freitas D, Deborska-Materkowska D, Debska-Slizien A, Djamali A, Domanski L, Durlik M, Einecke G, Eskandary F, Fatica R, Francis I, Fryc J, Gill J, Gill J, Glyda M, Gourishankar S, Gryczman M, Gupta G, Hruba P, Hughes P, Jittirat A, Jurekovic Z, Kamal L, Kamel M, Kant S, Kojc N, Konopa J, Lan J, Mannon RB, Matas A, Mazurkiewicz J, Miglinas M, Mueller T, Myslak M, Narins S, Naumnik B, Patel A, Perkowska-Ptasinska A, Picton M, Piecha G, Poggio E, Rajnochova Bloudickova S, Schachtner T, Shojai S, Sikosana ML, Slatinska J, Smykal-Jankowiak K, Solanki A, Veceric Haler Z, Viklicky O, Vucur K, Weir MR, Wiecek A, Wlodarczyk Z, Yang H, Zaky Z, Gauthier PT, Hinze C. A cross-sectional study of the role of epithelial cell injury in kidney transplant outcomes. JCI Insight. 2025 Apr 15;10(10):e188658. doi: 10.1172/jci.insight.188658. eCollection 2025 May 22.
- Background: PubMed 40301559Diebold M, Gauthier PT, Mayer KA, Mackova M, Hinze C, Chang J, Patel UD, Schutz E, Jilma B, Schrezenmeier E, Budde K, Bohmig GA, Halloran PF. Effect of felzartamab on the molecular phenotype of antibody-mediated rejection in kidney transplant biopsies. Nat Med. 2025 May;31(5):1668-1676. doi: 10.1038/s41591-025-03653-3. Epub 2025 Apr 29.
- Background: PubMed 40630324Callemeyn J, Nava-Sedeno JM, Anglicheau D, Beadle J, Brasen JH, Clahsen-van Groningen MC, Cristoferi I, de Loor H, Deutsch A, Essig M, Gwinner W, Halloran PF, Hesselink DA, Koshy P, Kuypers D, Lerut E, Marquet P, Minnee RC, Roufosse C, Sprangers B, Van Craenenbroeck AH, Hatzikirou H, Naesens M. Identification and Cross-Platform Validation of Sparse Molecular Classifiers for Antibody-Mediated and T-Cell-Mediated Rejection After Kidney Transplantation. Kidney Int Rep. 2025 Apr 1;10(6):1806-1818. doi: 10.1016/j.ekir.2025.03.048. eCollection 2025 Jun.
- Results publication: PubMed 23915426Halloran PF, Pereira AB, Chang J, Matas A, Picton M, De Freitas D, Bromberg J, Seron D, Sellares J, Einecke G, Reeve J. Potential impact of microarray diagnosis of T cell-mediated rejection in kidney transplants: The INTERCOM study. Am J Transplant. 2013 Sep;13(9):2352-63. doi: 10.1111/ajt.12387. Epub 2013 Aug 5.
- Results publication: PubMed 24119109Halloran PF, Pereira AB, Chang J, Matas A, Picton M, De Freitas D, Bromberg J, Seron D, Sellares J, Einecke G, Reeve J. Microarray diagnosis of antibody-mediated rejection in kidney transplant biopsies: an international prospective study (INTERCOM). Am J Transplant. 2013 Nov;13(11):2865-74. doi: 10.1111/ajt.12465. Epub 2013 Oct 3.
- Results publication: PubMed 24700874Loupy A, Lefaucheur C, Vernerey D, Chang J, Hidalgo LG, Beuscart T, Verine J, Aubert O, Dubleumortier S, Duong van Huyen JP, Jouven X, Glotz D, Legendre C, Halloran PF. Molecular microscope strategy to improve risk stratification in early antibody-mediated kidney allograft rejection. J Am Soc Nephrol. 2014 Oct;25(10):2267-77. doi: 10.1681/ASN.2013111149. Epub 2014 Apr 3.
- Results publication: PubMed 25377077Halloran PF, Chang J, Famulski K, Hidalgo LG, Salazar ID, Merino Lopez M, Matas A, Picton M, de Freitas D, Bromberg J, Seron D, Sellares J, Einecke G, Reeve J. Disappearance of T Cell-Mediated Rejection Despite Continued Antibody-Mediated Rejection in Late Kidney Transplant Recipients. J Am Soc Nephrol. 2015 Jul;26(7):1711-20. doi: 10.1681/ASN.2014060588. Epub 2014 Nov 6.
- Results publication: PubMed 26743766Halloran PF, Merino Lopez M, Barreto Pereira A. Identifying Subphenotypes of Antibody-Mediated Rejection in Kidney Transplants. Am J Transplant. 2016 Mar;16(3):908-20. doi: 10.1111/ajt.13551. Epub 2016 Jan 6.
- 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.
Philip F Halloran, MD PhD principal investigator
University of Alberta
26 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation Study of Molecular Diagnostic System and Development of Reporting System for Molecular Diagnosis, run by University of Alberta at 26 sites in 14 countries.
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 1 inclusion and 1 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada, France, Germany, Austria and 9 more countries. 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 Philip F Halloran, MD PhD (1 780 492-6160, phallora@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study (time frame: 2013-2016). 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 NCT01299168, which also lists 34 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 2 Jun 2026.