BIOBANK Renal Transplantation University Hospitals Leuven - Full Text View

Purpose

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.

Condition
Kidney Failure


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Biobank Renal Transplantation University Hospitals Leuven

Resource links provided by NLM:

MedlinePlus related topics: Health Facilities Kidney Transplantation

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:

Renal allograft survival [ Time Frame: 50 years after transplantation ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biopsy material (tissue, RNA, DNA) Peripheral blood samples (serum, plasma, RNA, DNA) Urine samples


Estimated Enrollment:	5000
Study Start Date:	March 2004
Estimated Study Completion Date:	December 2099
Estimated Primary Completion Date:	December 2099 (Final data collection date for primary outcome measure)

Groups/Cohorts
renal allograft donors and recipients All de novo renal allograft recipients transplanted at the University Hospitals Leuven

Detailed Description:

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

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

All donors and recipients of a kidney transplant at the University Hospitals Leuven

Criteria

Inclusion Criteria:

renal transplant recipients/donors

Exclusion Criteria:

none

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331668

Contacts


Contact: Maarten Naesens, MD, PhD	32 16344580	maarten.naesens@uzleuven.be

Locations


Belgium
Department of Nephrology and Renal Transplantation - University Hospitals Leuven	Recruiting
Leuven, BE, Belgium, 3000
Contact: Maarten Naesens, MD, PhD 32 16344580 maarten.naesens@uzleuven.be
Principal Investigator: Maarten Naesens, MD, PhD
Principal Investigator: Dirk Kuypers, MD, PhD

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators


Principal Investigator:	Maarten Naesens, MD, PhD	University Hospitals Leuven

More Information

Publications:

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. 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.

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. 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.

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.


Responsible Party:	Prof Dr Maarten Naesens, Prof. Dr. Maarten Naesens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT01331668 History of Changes
Other Study ID Numbers:	TRA-UZL-BIOBANK-001
Study First Received:	April 6, 2011
Last Updated:	March 25, 2014
Health Authority:	Belgium: Federal Agency for Medicines and Health Products, FAMHP

ClinicalTrials.gov processed this record on February 27, 2015