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BIOBANK Renal Transplantation University Hospitals Leuven

This study is currently recruiting participants.
Verified May 2016 by Prof Dr Maarten Naesens, Universitaire Ziekenhuizen Leuven
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331668
First Posted: April 8, 2011
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof Dr Maarten Naesens, Universitaire Ziekenhuizen Leuven
  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 Prof Dr Maarten Naesens, Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Renal allograft survival [ Time Frame: 50 years after transplantation ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 6, 2011
First Posted: April 8, 2011
Last Update Posted: May 11, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases


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