BIOBANK Nyretransplantasjon Universitetssykehus Leuven
6. mai 2024 oppdatert av: Prof Dr Maarten Naesens, Universitaire Ziekenhuizen KU Leuven
Biobank Nyretransplantasjon Universitetssykehus Leuven
Denne studien tar sikte på å opprettholde en prospektiv biobank av humane prøver hentet fra givere og mottakere av nyre-allotransplantater, inkludert biopsivev, perifere blodprøver og urinprøver.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
Kliniske data og bioprøver blir prospektivt samlet inn og lagret for udefinerte fremtidige translasjonsforskningsprosjekter.
Studietype
Observasjonsmessig
Registrering (Antatt)
5000
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Maarten Naesens, MD, PhD
- Telefonnummer: 32 16344580
- E-post: maarten.naesens@uzleuven.be
Studiesteder
-
-
BE
-
Leuven, BE, Belgia, 3000
- Rekruttering
- Department of Nephrology and Renal Transplantation - University Hospitals Leuven
-
Ta kontakt med:
- Maarten Naesens, MD, PhD
- Telefonnummer: 32 16344580
- E-post: maarten.naesens@uzleuven.be
-
Hovedetterforsker:
- Maarten Naesens, MD, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Alle givere og mottakere av en nyretransplantasjon ved universitetssykehusene i Leuven
Beskrivelse
Inklusjonskriterier:
- nyretransplanterte/donorer
Ekskluderingskriterier:
- ingen
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
nyreallotransplanterte donorer og mottakere
Alle de novo nyreallograftmottakere transplantert ved universitetssykehusene i Leuven
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Renal allograft overlevelse
Tidsramme: 50 år etter transplantasjon
|
50 år etter transplantasjon
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Maarten Naesens, MD, PhD, Universitaire Ziekenhuizen KU Leuven
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Naesens M, Heylen L. Intrarenal resistive index after renal transplantation. N Engl J Med. 2014 Feb 13;370(7):677-8. doi: 10.1056/NEJMc1315502. No abstract available.
- Kuypers DR, de Jonge H, Naesens M, Vanrenterghem Y. A prospective, open-label, observational clinical cohort study of the association between delayed renal allograft function, tacrolimus exposure, and CYP3A5 genotype in adult recipients. Clin Ther. 2010 Nov;32(12):2012-23. doi: 10.1016/j.clinthera.2010.11.010.
- Kuypers DR, Naesens M, de Jonge H, Lerut E, Verbeke K, Vanrenterghem Y. Tacrolimus dose requirements and CYP3A5 genotype and the development of calcineurin inhibitor-associated nephrotoxicity in renal allograft recipients. Ther Drug Monit. 2010 Aug;32(4):394-404. doi: 10.1097/FTD.0b013e3181e06818.
- Naesens M, Lerut E, de Jonge H, Van Damme B, Vanrenterghem Y, Kuypers DR. Donor age and renal P-glycoprotein expression associate with chronic histological damage in renal allografts. J Am Soc Nephrol. 2009 Nov;20(11):2468-80. doi: 10.1681/ASN.2009020192. Epub 2009 Sep 17.
- Evenepoel P, Lerut E, Naesens M, Bammens B, Claes K, Kuypers D, Vermeersch P, Meijers B, Van Damme B, Vanrenterghem Y. Localization, etiology and impact of calcium phosphate deposits in renal allografts. Am J Transplant. 2009 Nov;9(11):2470-8. doi: 10.1111/j.1600-6143.2009.02792.x. Epub 2009 Aug 14.
- Naesens M, Li L, Ying L, Sansanwal P, Sigdel TK, Hsieh SC, Kambham N, Lerut E, Salvatierra O, Butte AJ, Sarwal MM. Expression of complement components differs between kidney allografts from living and deceased donors. J Am Soc Nephrol. 2009 Aug;20(8):1839-51. doi: 10.1681/ASN.2008111145. Epub 2009 May 14.
- Evenepoel P, Van Den Bergh B, Naesens M, De Jonge H, Bammens B, Claes K, Kuypers D, Vanrenterghem Y. Calcium metabolism in the early posttransplantation period. Clin J Am Soc Nephrol. 2009 Mar;4(3):665-72. doi: 10.2215/CJN.03920808. Epub 2009 Mar 4.
- Evenepoel P, Meijers BK, de Jonge H, Naesens M, Bammens B, Claes K, Kuypers D, Vanrenterghem Y. Recovery of hyperphosphatoninism and renal phosphorus wasting one year after successful renal transplantation. Clin J Am Soc Nephrol. 2008 Nov;3(6):1829-36. doi: 10.2215/CJN.01310308. Epub 2008 Oct 15.
- Kuypers DR, de Jonge H, Naesens M, Vanrenterghem Y. Effects of CYP3A5 and MDR1 single nucleotide polymorphisms on drug interactions between tacrolimus and fluconazole in renal allograft recipients. Pharmacogenet Genomics. 2008 Oct;18(10):861-8. doi: 10.1097/FPC.0b013e328307c26e.
- Naesens M, Lerut E, Damme BV, Vanrenterghem Y, Kuypers DR. Tacrolimus exposure and evolution of renal allograft histology in the first year after transplantation. Am J Transplant. 2007 Sep;7(9):2114-23. doi: 10.1111/j.1600-6143.2007.01892.x. Epub 2007 Jul 3.
- Lerut E, Naesens M, Kuypers DR, Vanrenterghem Y, Van Damme B. Subclinical peritubular capillaritis at 3 months is associated with chronic rejection at 1 year. Transplantation. 2007 Jun 15;83(11):1416-22. doi: 10.1097/01.tp.0000266676.10550.70.
- Evenepoel P, Naesens M, Claes K, Kuypers D, Vanrenterghem Y. Tertiary 'hyperphosphatoninism' accentuates hypophosphatemia and suppresses calcitriol levels in renal transplant recipients. Am J Transplant. 2007 May;7(5):1193-200. doi: 10.1111/j.1600-6143.2007.01753.x. Epub 2007 Mar 12.
- Evenepoel P, Bammens B, Claes K, Kuypers D, Meijers BK, Vanrenterghem Y. Measuring total blood calcium displays a low sensitivity for the diagnosis of hypercalcemia in incident renal transplant recipients. Clin J Am Soc Nephrol. 2010 Nov;5(11):2085-92. doi: 10.2215/CJN.02460310. Epub 2010 Sep 9.
- Kanaan N, Claes K, Devogelaer JP, Vanderschueren D, Depresseux G, Goffin E, Evenepoel P. Fibroblast growth factor-23 and parathyroid hormone are associated with post-transplant bone mineral density loss. Clin J Am Soc Nephrol. 2010 Oct;5(10):1887-92. doi: 10.2215/CJN.00950110. Epub 2010 Jul 15.
- Claes K, Bammens B, Evenepoel P, Kuypers D, Coosemans W, Darius T, Monbaliu D, Pirenne J, Vanrenterghem Y. Troponin I is a predictor of acute cardiac events in the immediate postoperative renal transplant period. Transplantation. 2010 Feb 15;89(3):341-6. doi: 10.1097/TP.0b013e3181bc405e.
- Naesens M, Heylen L, Lerut E, Claes K, De Wever L, Claus F, Oyen R, Kuypers D, Evenepoel P, Bammens B, Sprangers B, Meijers B, Pirenne J, Monbaliu D, de Jonge H, Metalidis C, De Vusser K, Vanrenterghem Y. Intrarenal resistive index after renal transplantation. N Engl J Med. 2013 Nov 7;369(19):1797-806. doi: 10.1056/NEJMoa1301064.
- Khatri P, Roedder S, Kimura N, De Vusser K, Morgan AA, Gong Y, Fischbein MP, Robbins RC, Naesens M, Butte AJ, Sarwal MM. A common rejection module (CRM) for acute rejection across multiple organs identifies novel therapeutics for organ transplantation. J Exp Med. 2013 Oct 21;210(11):2205-21. doi: 10.1084/jem.20122709. Epub 2013 Oct 14.
- De Vusser K, Lerut E, Kuypers D, Vanrenterghem Y, Jochmans I, Monbaliu D, Pirenne J, Naesens M. The predictive value of kidney allograft baseline biopsies for long-term graft survival. J Am Soc Nephrol. 2013 Nov;24(11):1913-23. doi: 10.1681/ASN.2012111081. Epub 2013 Aug 15.
- Metalidis C, van Vuuren SH, Broekhuizen R, Lerut E, Naesens M, Bakker SJ, Wetzels JF, Goldschmeding R, Kuypers DR. Urinary connective tissue growth factor is associated with human renal allograft fibrogenesis. Transplantation. 2013 Sep 15;96(5):494-500. doi: 10.1097/TP.0b013e31829b07e1.
- Naesens M, Kuypers DR, De Vusser K, Vanrenterghem Y, Evenepoel P, Claes K, Bammens B, Meijers B, Lerut E. Chronic histological damage in early indication biopsies is an independent risk factor for late renal allograft failure. Am J Transplant. 2013 Jan;13(1):86-99. doi: 10.1111/j.1600-6143.2012.04304.x. Epub 2012 Nov 8.
- Lenain R, Dantan E, Giral M, Foucher Y, Asar O, Naesens M, Hazzan M, Fournier MC. External Validation of the DynPG for Kidney Transplant Recipients. Transplantation. 2021 Feb 1;105(2):396-403. doi: 10.1097/TP.0000000000003209.
- Van Loon E, Senev A, Lerut E, Coemans M, Callemeyn J, Van Keer JM, Daniels L, Kuypers D, Sprangers B, Emonds MP, Naesens M. Assessing the Complex Causes of Kidney Allograft Loss. Transplantation. 2020 Dec;104(12):2557-2566. doi: 10.1097/TP.0000000000003192.
- Senev A, Otten HG, Kamburova EG, Callemeyn J, Lerut E, Van Sandt V, Kuypers D, Emonds MP, Naesens M. Antibodies Against ARHGDIB and ARHGDIB Gene Expression Associate With Kidney Allograft Outcome. Transplantation. 2020 Jul;104(7):1462-1471. doi: 10.1097/TP.0000000000003005.
- Heylen L, Thienpont B, Busschaert P, Sprangers B, Kuypers D, Moisse M, Lerut E, Lambrechts D, Naesens M. Age-related changes in DNA methylation affect renal histology and post-transplant fibrosis. Kidney Int. 2019 Nov;96(5):1195-1204. doi: 10.1016/j.kint.2019.06.018. Epub 2019 Jul 10.
- Van Loon E, Gazut S, Yazdani S, Lerut E, de Loor H, Coemans M, Noel LH, Thorrez L, Van Lommel L, Schuit F, Sprangers B, Kuypers D, Essig M, Gwinner W, Anglicheau D, Marquet P, Naesens M. Development and validation of a peripheral blood mRNA assay for the assessment of antibody-mediated kidney allograft rejection: A multicentre, prospective study. EBioMedicine. 2019 Aug;46:463-472. doi: 10.1016/j.ebiom.2019.07.028. Epub 2019 Aug 1.
- Zhang W, Yi Z, Keung KL, Shang H, Wei C, Cravedi P, Sun Z, Xi C, Woytovich C, Farouk S, Huang W, Banu K, Gallon L, Magee CN, Najafian N, Samaniego M, Djamali A, Alexander SI, Rosales IA, Smith RN, Xiang J, Lerut E, Kuypers D, Naesens M, O'Connell PJ, Colvin R, Menon MC, Murphy B. A Peripheral Blood Gene Expression Signature to Diagnose Subclinical Acute Rejection. J Am Soc Nephrol. 2019 Aug;30(8):1481-1494. doi: 10.1681/ASN.2018111098. Epub 2019 Jul 5.
- Senev A, Lerut E, Van Sandt V, Coemans M, Callemeyn J, Sprangers B, Kuypers D, Emonds MP, Naesens M. Specificity, strength, and evolution of pretransplant donor-specific HLA antibodies determine outcome after kidney transplantation. Am J Transplant. 2019 Nov;19(11):3100-3113. doi: 10.1111/ajt.15414. Epub 2019 Jun 19.
- Cippa PE, Liu J, Sun B, Kumar S, Naesens M, McMahon AP. A late B lymphocyte action in dysfunctional tissue repair following kidney injury and transplantation. Nat Commun. 2019 Mar 11;10(1):1157. doi: 10.1038/s41467-019-09092-2.
- Coemans M, Van Loon E, Lerut E, Gillard P, Sprangers B, Senev A, Emonds MP, Van Keer J, Callemeyn J, Daniels L, Sichien J, Verbeke G, Kuypers D, Mathieu C, Naesens M. Occurrence of Diabetic Nephropathy After Renal Transplantation Despite Intensive Glycemic Control: An Observational Cohort Study. Diabetes Care. 2019 Apr;42(4):625-634. doi: 10.2337/dc18-1936. Epub 2019 Feb 14.
- Senev A, Callemeyn J, Lerut E, Emonds MP, Naesens M. Histological picture of ABMR without HLA-DSA: Temporal dynamics of effector mechanisms are relevant in disease reclassification. Am J Transplant. 2019 Mar;19(3):954-955. doi: 10.1111/ajt.15234. Epub 2019 Jan 24. No abstract available.
- Cippa PE, Sun B, Liu J, Chen L, Naesens M, McMahon AP. Transcriptional trajectories of human kidney injury progression. JCI Insight. 2018 Nov 15;3(22):e123151. doi: 10.1172/jci.insight.123151.
- Yazdani S, Callemeyn J, Gazut S, Lerut E, de Loor H, Wevers M, Heylen L, Saison C, Koenig A, Thaunat O, Thorrez L, Kuypers D, Sprangers B, Noel LH, Van Lommel L, Schuit F, Essig M, Gwinner W, Anglicheau D, Marquet P, Naesens M. Natural killer cell infiltration is discriminative for antibody-mediated rejection and predicts outcome after kidney transplantation. Kidney Int. 2019 Jan;95(1):188-198. doi: 10.1016/j.kint.2018.08.027. Epub 2018 Nov 3.
- Senev A, Coemans M, Lerut E, Van Sandt V, Daniels L, Kuypers D, Sprangers B, Emonds MP, Naesens M. Histological picture of antibody-mediated rejection without donor-specific anti-HLA antibodies: Clinical presentation and implications for outcome. Am J Transplant. 2019 Mar;19(3):763-780. doi: 10.1111/ajt.15074. Epub 2018 Sep 28.
- Heylen L, Thienpont B, Naesens M, Busschaert P, Depreeuw J, Smeets D, Jochmans I, Monbaliu D, Pirenne J, Lerut E, Ghesquiere B, Kuypers D, Lambrechts D, Sprangers B. Ischemia-Induced DNA Hypermethylation during Kidney Transplant Predicts Chronic Allograft Injury. J Am Soc Nephrol. 2018 May;29(5):1566-1576. doi: 10.1681/ASN.2017091027. Epub 2018 Apr 2.
- Azad TD, Donato M, Heylen L, Liu AB, Shen-Orr SS, Sweeney TE, Maltzman JS, Naesens M, Khatri P. Inflammatory macrophage-associated 3-gene signature predicts subclinical allograft injury and graft survival. JCI Insight. 2018 Jan 25;3(2):e95659. doi: 10.1172/jci.insight.95659. eCollection 2018 Jan 25.
- De Vusser K, Pieters N, Janssen B, Lerut E, Kuypers D, Jochmans I, Monbaliu D, Pirenne J, Nawrot T, Naesens M. Telomere length, cardiovascular risk and arteriosclerosis in human kidneys: an observational cohort study. Aging (Albany NY). 2015 Oct;7(10):766-75. doi: 10.18632/aging.100814.
- Naesens M, Lerut E, Emonds MP, Herelixka A, Evenepoel P, Claes K, Bammens B, Sprangers B, Meijers B, Jochmans I, Monbaliu D, Pirenne J, Kuypers DR. Proteinuria as a Noninvasive Marker for Renal Allograft Histology and Failure: An Observational Cohort Study. J Am Soc Nephrol. 2016 Jan;27(1):281-92. doi: 10.1681/ASN.2015010062. Epub 2015 Jul 7.
- Delville M, Sigdel TK, Wei C, Li J, Hsieh SC, Fornoni A, Burke GW, Bruneval P, Naesens M, Jackson A, Alachkar N, Canaud G, Legendre C, Anglicheau D, Reiser J, Sarwal MM. A circulating antibody panel for pretransplant prediction of FSGS recurrence after kidney transplantation. Sci Transl Med. 2014 Oct 1;6(256):256ra136. doi: 10.1126/scitranslmed.3008538.
- Douwes RM, Gomes-Neto AW, Eisenga MF, Van Loon E, Schutten JC, Gans ROB, Naesens M, van den Berg E, Sprangers B, Berger SP, Navis G, Blokzijl H, Meijers B, Bakker SJL, Kuypers D. The association between use of proton-pump inhibitors and excess mortality after kidney transplantation: A cohort study. PLoS Med. 2020 Jun 15;17(6):e1003140. doi: 10.1371/journal.pmed.1003140. eCollection 2020 Jun.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2004
Primær fullføring (Antatt)
1. desember 2099
Studiet fullført (Antatt)
1. desember 2099
Datoer for studieregistrering
Først innsendt
6. april 2011
Først innsendt som oppfylte QC-kriteriene
6. april 2011
Først lagt ut (Antatt)
8. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. mai 2024
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mai 2024
Sist bekreftet
1. mai 2024
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TRA-UZL-BIOBANK-001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .