Kidney Transplant RejectionNCT06505200
Observational Cohort Study Renal Transplantation University Hospitals Leuven
An observational study of Kidney Transplant Rejection and Kidney Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This observational cohort study aims to compile routinely collected clinical, histological and outcome data of kidney transplant recipients, to evaluate risk factors for post-transplant injury, phenotypes of injury, and impact on outcome of such injury, in order to provide clinicians more accurate, less biased and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection, Kidney Transplantation, Kidney Transplant Failure
- How many people
- 1,891 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2004to 31 Dec 2027
- Phase
- Observational
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: All renal allograft recipients transplanted at the University Hospitals Leuven between 01/03/2004 and 01/06/2022 are included in this study, without restrictions with regard to age, sex, underlying kidney disease etc.
Who may be able to join
- All adult kidney transplant recipients transplanted at the University Hospitals Leuven between 01/03/2004 and 01/06/2022, without restrictions with regard to age, sex, underlying kidney disease etc.
Who cannot join
- Patients with combined transplantations (e.g. heart + kidney, liver + kidney, lung + kidney)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Integrative Clinicopathological Decision Support System for Kidney Transplant Rejection
This observational cohort study aims to compile routinely collected clinical, histological and outcome data of kidney transplant recipients, to evaluate risk factors for post-transplant injury, phenotypes of injury, and impact on outcome of such injury, in order to provide clinicians more accurate, less biased and faster tools for diagnosis, clinical management and treatment decisions with regard to kidney transplant rejection.
Read the detailed description
The following data/features are collected prospectively and structured in the electronic medical records:
Demographics:
- Date of transplantation
- Date of graft failure
- Last date of follow-up
- Time after transplantation of survival (number of days);
- kidney survival;
- recipient death;
- recipient gender;
- recipient age at time of transplantation;
- recipient weight at time of transplantation;
- recipient BMI at time of transplantation;
- recipient race;
- recipient diabetes prior to transplantation;
- the Belgian Index for Multiple Deprivation (BIMD);
- combined vs single transplant (we included only single transplants);
- repeat transplant vs. first transplant;
- diagnosis of the original kidney disease (prior to transplantation);
- donor type (living vs. deceased);
- donor gender;
- donor age in years;
- donor diabetes yes vs no;
- HLA genotype of donors and recipients, number of HLA A mismatches between donor and recipient (0-2); number of HLA B mismatches between donor and recipient (0-2); number of HLA DR mismatches between donor and recipient (0-2); number of total HLA mismatches between donor and recipient (0-6); high-resolution genotyping of donors and recipients HLA genes (11 loci);
- cold ischemia time
- warm ischemia time
- operation time
Graft functional data:
- Serum creatinine values from day of transplantation onwards;
- Proteinuria values from day of transplantation onwards
Data on DSA:
DSA data collected in clinical routine, from the day of listing for transplantation onwards (clinically measured at the Histocompatibility laboratory of the Red Cross, Motstraat, Mechelen, and reported in the clinical patient records).
Biopsy data:
Both clinically indicated and protocol biopsies were performed in this cohort. On average, 3.2 biopsies per patient.
- The following data are collected from the clinical records and transferred to a pseudonymized database: Date of the kidney biopsy; Indication biopsy = at time of graft dysfunction; protocol = prespecified biopsy per protocol; pretransplant = biopsy prior to transplantation (in the donor); post-transplant = biopsy after transplantation; time point (indication vs. Protocol biopsy time points); tubulitis (0-3); interstitial inflammation (0-3); vasculitis (0-3); glomerulitis (0-3); peritubular capillaritis (0-3); thrombi (0-3); C4d deposition in peritubular capillaries (0-3); C4d deposition in glomerular capillaries (0-3); transplant glomerulopathy (0-3); interstitial fibrosis (0-3); tubular atrophy (0-3); vascular intimal thickening (0-3); mesangial matrix increase (0-3); arteriolar hyalinosis (0-3); glomerulosclerosis (%); microcirculatory inflammation (0-6) = g + ptc; diagnosis of antibody-mediated rejection yes vs no according to current international consensus, calculated from g, ptc, cg, thrombi, C4d_ptc and v; diagnosis of T-cell mediated rejection yes vs no according to current international consensus (0 = absent, 1 = borderline; 1=present); diagnosis of IFTA grade (0-3) according to current international consensus: calculated from ci and ct
- Next to pseudonymized clinical data, also histological slides are retrieved from the biobank of the Department of Pathology of the University Hospitals Leuven and whole slide images made available for image analysis.
- Being tested
- No intervention
- Keywords
- Clinical Decision Support, Outcome, Risk Markers, Stratification, Histology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney transplant failure
Graft failure, recipient death
Measured: 2004 - 2022
Secondary outcomes (2)
Kidney transplant rejection phenotypes
Measured: 2004 - 2022
Kidney transplant function
Measured: 2004 - 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Mar 2004
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 1,891 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maarten Naesens, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505200
- Sponsor's protocol ID
- S64006
- Status last verified
- Apr 2026
- First submitted
- 10 Jul 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data can only be made available to other researchers with a dedicated data transfer agreement.
Publications
Cleenders E, Coemans M, Meziyerh S, Callemeyn J, Emonds MP, Gwinner W, Kers J, Kuypers D, Scheffner I, Senev A, Van Loon E, Wellekens K, de Vries APJ, Verbeke G, Naesens M. An observational cohort study examined the change point of kidney function stabilization in the initial period after transplantation. Kidney Int. 2024 Sep;106(3):508-521. doi: 10.1016/j.kint.2024.05.030. Epub 2024 Jun 28.
PubMed 38945395Debyser T, Callemeyn J, Coemans M, Kerkhofs J, Koshy P, Kuypers D, Senev A, Tambur AR, Van Loon E, Wellekens K, Naesens M, Emonds MP. Sensitive HLA antibody testing and the risk of antibody-mediated rejection and graft failure. HLA. 2024 Jun;103(6):e15586. doi: 10.1111/tan.15586.
PubMed 38932739Yoo D, Divard G, Raynaud M, Cohen A, Mone TD, Rosenthal JT, Bentall AJ, Stegall MD, Naesens M, Zhang H, Wang C, Gueguen J, Kamar N, Bouquegneau A, Batal I, Coley SM, Gill JS, Oppenheimer F, De Sousa-Amorim E, Kuypers DRJ, Durrbach A, Seron D, Rabant M, Van Huyen JD, Campbell P, Shojai S, Mengel M, Bestard O, Basic-Jukic N, Juric I, Boor P, Cornell LD, Alexander MP, Toby Coates P, Legendre C, Reese PP, Lefaucheur C, Aubert O, Loupy A. A Machine Learning-Driven Virtual Biopsy System For Kidney Transplant Patients. Nat Commun. 2024 Jan 16;15(1):554. doi: 10.1038/s41467-023-44595-z.
PubMed 38228634Yi Z, Xi C, Menon MC, Cravedi P, Tedla F, Soto A, Sun Z, Liu K, Zhang J, Wei C, Chen M, Wang W, Veremis B, Garcia-Barros M, Kumar A, Haakinson D, Brody R, Azeloglu EU, Gallon L, O'Connell P, Naesens M, Shapiro R, Colvin RB, Ward S, Salem F, Zhang W. A large-scale retrospective study enabled deep-learning based pathological assessment of frozen procurement kidney biopsies to predict graft loss and guide organ utilization. Kidney Int. 2024 Feb;105(2):281-292. doi: 10.1016/j.kint.2023.09.031. Epub 2023 Nov 3.
PubMed 37923131Cleenders E, Koshy P, Van Loon E, Lagrou K, Beuselinck K, Andrei G, Crespo M, De Vusser K, Kuypers D, Lerut E, Mertens K, Mineeva-Sangwo O, Randhawa P, Senev A, Snoeck R, Sprangers B, Tinel C, Van Craenenbroeck A, van den Brand J, Van Ranst M, Verbeke G, Coemans M, Naesens M. An observational cohort study of histological screening for BK polyomavirus nephropathy following viral replication in plasma. Kidney Int. 2023 Nov;104(5):1018-1034. doi: 10.1016/j.kint.2023.07.025. Epub 2023 Aug 19.
PubMed 37598855Truchot A, Raynaud M, Kamar N, Naesens M, Legendre C, Delahousse M, Thaunat O, Buchler M, Crespo M, Linhares K, Orandi BJ, Akalin E, Pujol GS, Silva HT Jr, Gupta G, Segev DL, Jouven X, Bentall AJ, Stegall MD, Lefaucheur C, Aubert O, Loupy A. Machine learning does not outperform traditional statistical modelling for kidney allograft failure prediction. Kidney Int. 2023 May;103(5):936-948. doi: 10.1016/j.kint.2022.12.011. Epub 2022 Dec 23.
PubMed 36572246Vaulet T, Divard G, Thaunat O, Koshy P, Lerut E, Senev A, Aubert O, Van Loon E, Callemeyn J, Emonds MP, Van Craenenbroeck A, De Vusser K, Sprangers B, Rabeyrin M, Dubois V, Kuypers D, De Vos M, Loupy A, De Moor B, Naesens M. Data-Driven Chronic Allograft Phenotypes: A Novel and Validated Complement for Histologic Assessment of Kidney Transplant Biopsies. J Am Soc Nephrol. 2022 Nov;33(11):2026-2039. doi: 10.1681/ASN.2022030290. Epub 2022 Sep 7.
PubMed 36316096Coemans M, Verbeke G, Dohler B, Susal C, Naesens M. Bias by censoring for competing events in survival analysis. BMJ. 2022 Sep 13;378:e071349. doi: 10.1136/bmj-2022-071349. No abstract available.
PubMed 36100269Senev A, Van Loon E, Lerut E, Coemans M, Callemeyn J, Daniels L, Kerkhofs J, Koshy P, Kuypers D, Lamarthee B, Sprangers B, Tinel C, Van Craenenbroeck AH, Van Sandt V, Emonds MP, Naesens M. Association of Predicted HLA T-Cell Epitope Targets and T-Cell-Mediated Rejection After Kidney Transplantation. Am J Kidney Dis. 2022 Dec;80(6):718-729.e1. doi: 10.1053/j.ajkd.2022.04.009. Epub 2022 Jun 9.
PubMed 35690154Senev A, Lerut E, Coemans M, Callemeyn J, Copley HC, Claas F, Koshy P, Kosmoliaptsis V, Kuypers D, Sprangers B, Van Craenenbroeck A, Van Loon E, Van Sandt V, Emonds MP, Naesens M. Association of HLA Mismatches and Histology Suggestive of Antibody-Mediated Injury in the Absence of Donor-Specific Anti-HLA Antibodies. Clin J Am Soc Nephrol. 2022 Aug;17(8):1204-1215. doi: 10.2215/CJN.00570122. Epub 2022 Jun 1.
PubMed 35649719Van Loon E, Zhang W, Coemans M, De Vos M, Emonds MP, Scheffner I, Gwinner W, Kuypers D, Senev A, Tinel C, Van Craenenbroeck AH, De Moor B, Naesens M. Forecasting of Patient-Specific Kidney Transplant Function With a Sequence-to-Sequence Deep Learning Model. JAMA Netw Open. 2021 Dec 1;4(12):e2141617. doi: 10.1001/jamanetworkopen.2021.41617.
PubMed 34967877Kers J, Bulow RD, Klinkhammer BM, Breimer GE, Fontana F, Abiola AA, Hofstraat R, Corthals GL, Peters-Sengers H, Djudjaj S, von Stillfried S, Holscher DL, Pieters TT, van Zuilen AD, Bemelman FJ, Nurmohamed AS, Naesens M, Roelofs JJTH, Florquin S, Floege J, Nguyen TQ, Kather JN, Boor P. Deep learning-based classification of kidney transplant pathology: a retrospective, multicentre, proof-of-concept study. Lancet Digit Health. 2022 Jan;4(1):e18-e26. doi: 10.1016/S2589-7500(21)00211-9. Epub 2021 Nov 15.
PubMed 34794930Callemeyn J, Senev A, Coemans M, Lerut E, Sprangers B, Kuypers D, Koenig A, Thaunat O, Emonds MP, Naesens M. Missing Self-Induced Microvascular Rejection of Kidney Allografts: A Population-Based Study. J Am Soc Nephrol. 2021 Aug;32(8):2070-2082. doi: 10.1681/ASN.2020111558. Epub 2021 Jul 22.
PubMed 34301794Coemans M, Senev A, Van Loon E, Lerut E, Sprangers B, Kuypers D, Emonds MP, Verbeke G, Naesens M. The evolution of histological changes suggestive of antibody-mediated injury, in the presence and absence of donor-specific anti-HLA antibodies. Transpl Int. 2021 Oct;34(10):1824-1836. doi: 10.1111/tri.13964. Epub 2021 Sep 12.
PubMed 34197662Senev A, Emonds MP, Naesens M. Second field high-resolution HLA typing for immunologic risk stratification in kidney transplantation. Am J Transplant. 2021 Oct;21(10):3502-3503. doi: 10.1111/ajt.16606. Epub 2021 Apr 30. No abstract available.
PubMed 33866671