Clinical trial NCT01331668: BIOBANK Renal Transplantation University Hospitals Leuven
Official title: Biobank Renal Transplantation University Hospitals Leuven
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Failure
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-04-08
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All donors and recipients of a kidney transplant at the University Hospitals Leuven

Brief summary: This study aims to maintain a prospective biobank of human samples obtained from donors and recipients of renal allografts, including biopsy tissue, peripheral blood samples and urine samples.

Detailed description: Clinical data and bio-specimens are prospectively collected and stored for undefined future translational research projects.

Eligibility criteria: Inclusion Criteria:

* renal transplant recipients/donors

Exclusion Criteria:

* none

Primary outcomes:
measure: Renal allograft survival
timeFrame: 50 years after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Nephrology and Renal Transplantation - University Hospitals Leuven
state: BE
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Maarten Naesens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.