Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-02 @ 8:53 AM
Study NCT ID:
NCT02811835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2017-08-22
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN)
Sponsor:
Organization:
Raw JSON
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Higher Urinary Iron Levels Are Associated with Kidney Dysfunction, Tubular Damage, and Increased Mortality in Kidney Transplant Recipients. Kidney360. 2025 Nov 1;6(11):1970-1980. doi: 10.34067/KID.0000000878. Epub 2025 Jun 26.'}, {'pmid': '38869518', 'type': 'DERIVED', 'citation': 'Post A, Groothof D, Kremer D, Knobbe TJ, Abma W, Koops CA, Tsikas D, Wallimann T, Dullaart RPF, Franssen CFM, Kema IP, Heiner-Fokkema MR, Bakker SJL. Creatine homeostasis and the kidney: comparison between kidney transplant recipients and healthy controls. Amino Acids. 2024 Jun 13;56(1):42. doi: 10.1007/s00726-024-03401-w.'}, {'pmid': '36564033', 'type': 'DERIVED', 'citation': 'Post A, Kremer D, Groothof D, Seidel U, Huebbe P, Franssen CFM, Kema IP, Luersen K, Rimbach G, Bakker SJL. Dietary lithium intake, graft failure and mortality in kidney transplant recipients. Nephrol Dial Transplant. 2023 Jul 31;38(8):1867-1879. doi: 10.1093/ndt/gfac340.'}, {'pmid': '36535643', 'type': 'DERIVED', 'citation': 'Kremer D, Alkaff FF, Post A, Knobbe TJ, Tepel M, Thaunat O, Berger SP, van den Born J, Genovese F, Karsdal MA, Rasmussen DGK, Bakker SJL. Plasma endotrophin, reflecting tissue fibrosis, is associated with graft failure and mortality in KTRs: results from two prospective cohort studies. Nephrol Dial Transplant. 2023 Mar 31;38(4):1041-1052. doi: 10.1093/ndt/gfac332.'}, {'pmid': '35470855', 'type': 'DERIVED', 'citation': 'Oste MCJ, Duan MJ, Gomes-Neto AW, Vinke PC, Carrero JJ, Avesani C, Cai Q, Dekker LH, Navis GJ, Bakker SJL, Corpeleijn E. Ultra-processed foods and risk of all-cause mortality in renal transplant recipients. Am J Clin Nutr. 2022 Jun 7;115(6):1646-1657. doi: 10.1093/ajcn/nqac053.'}, {'pmid': '35145638', 'type': 'DERIVED', 'citation': 'Kremer D, Post A, Gomes-Neto AW, Groothof D, Kunutsor SK, Nilsen T, Hidden C, Sundrehagen E, Eisenga MF, Navis G, Bakker SJL; TransplantLines Investigators. Plasma neutrophil gelatinase-associated lipocalin and kidney graft outcome. Clin Kidney J. 2021 Nov 8;15(2):235-243. doi: 10.1093/ckj/sfab219. eCollection 2022 Feb.'}, {'pmid': '34610923', 'type': 'DERIVED', 'citation': 'Stam SP, Sokooti S, Eisenga MF, van der Veen A, Gomes-Neto AW, van Dijk PR, van Zanden JJ, Vos MJ, Kema IP, van Beek AP, Bakker SJL; TransplantLines Investigators. Androgens and Development of Posttransplantation Diabetes Mellitus in Male Kidney Transplant Recipients: A Post Hoc Analysis of a Prospective Study. Diabetes Care. 2021 Dec;44(12):2683-2690. doi: 10.2337/dc21-0237. Epub 2021 Oct 5.'}, {'pmid': '34135022', 'type': 'DERIVED', 'citation': 'Yeung SMH, Gomes-Neto AW, Oste MCJ, van den Berg E, Kootstra-Ros JE, Sanders JSF, Berger SP, Carrero JJ, De Borst MH, Navis GJ, Bakker SJL. Net Endogenous Acid Excretion and Kidney Allograft Outcomes. Clin J Am Soc Nephrol. 2021 Sep;16(9):1398-1406. doi: 10.2215/CJN.00780121. Epub 2021 Jun 16.'}, {'pmid': '33618925', 'type': 'DERIVED', 'citation': 'Cai Q, Oste MCJ, Gomes-Neto AW, Dekker LH, Borgonjen-van den Berg KJ, Geleijnse JM, Bakker SJL, de Borst MH, Navis GJ. Metabolic syndrome-related dietary pattern and risk of mortality in kidney transplant recipients. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1129-1136. doi: 10.1016/j.numecd.2021.01.005. Epub 2021 Jan 19.'}, {'pmid': '33577985', 'type': 'DERIVED', 'citation': 'Klont F, Kremer D, Gomes Neto AW, Berger SP, Touw DJ, Hak E, Bonner R, Bakker SJL, Hopfgartner G. Metabolomics data complemented drug use information in epidemiological databases: pilot study of potential kidney donors. J Clin Epidemiol. 2021 Jul;135:10-16. doi: 10.1016/j.jclinepi.2021.02.008. Epub 2021 Feb 9.'}, {'pmid': '33316268', 'type': 'DERIVED', 'citation': 'Sotomayor CG, Oskooei SS, Bustos NI, Nolte IM, Gomes-Neto AW, Erazo M, Gormaz JG, Berger SP, Navis GJ, Rodrigo R, Dullaart RPF, Bakker SJL. Serum uric acid is associated with increased risk of posttransplantation diabetes in kidney transplant recipients: a prospective cohort study. Metabolism. 2021 Mar;116:154465. doi: 10.1016/j.metabol.2020.154465. Epub 2020 Dec 13.'}, {'pmid': '33071013', 'type': 'DERIVED', 'citation': 'Post A, Said MY, Gomes-Neto AW, Minovic I, Groothof D, Swarte JC, Boer T, Kema IP, Heiner-Fokkema MR, Franssen CFM, Bakker SJL. Urinary 3-hydroxyisovaleryl carnitine excretion, protein energy malnutrition and risk of all-cause mortality in kidney transplant recipients: Results from the TransplantLines cohort studies. Clin Nutr. 2021 Apr;40(4):2109-2120. doi: 10.1016/j.clnu.2020.09.035. Epub 2020 Oct 1.'}, {'pmid': '32941876', 'type': 'DERIVED', 'citation': 'Sotomayor CG, Groothof D, Vodegel JJ, Eisenga MF, Knobbe TJ, IJmker J, Lammerts RGM, de Borst MH, Berger SP, Nolte IM, Rodrigo R, Slart RHJA, Navis GJ, Touw DJ, Bakker SJL. Plasma cadmium is associated with increased risk of long-term kidney graft failure. Kidney Int. 2021 May;99(5):1213-1224. doi: 10.1016/j.kint.2020.08.027. Epub 2020 Sep 14.'}, {'pmid': '32542023', 'type': 'DERIVED', '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.'}, {'pmid': '32052523', 'type': 'DERIVED', 'citation': 'Vulto A, Minovic I, de Vries LV, Timmermans AC, van Faassen M, Gomes Neto AW, Touw DJ, de Jong MFC, van Beek AP, Dullaart RPF, Navis G, Kema IP, Bakker SJL. Endogenous urinary glucocorticoid metabolites and mortality in prednisolone-treated renal transplant recipients. Clin Transplant. 2020 Apr;34(4):e13824. doi: 10.1111/ctr.13824. Epub 2020 Mar 3.'}, {'pmid': '31896540', 'type': 'DERIVED', 'citation': 'Gomes-Neto AW, Oste MCJ, Sotomayor CG, van den Berg E, Geleijnse JM, Berger SP, Gans ROB, Bakker SJL, Navis GJ. Mediterranean Style Diet and Kidney Function Loss in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2020 Feb 7;15(2):238-246. doi: 10.2215/CJN.06710619. Epub 2020 Jan 2.'}, {'pmid': '31296643', 'type': 'DERIVED', 'citation': 'Gomes-Neto AW, Oste MCJ, Sotomayor CG, V D Berg E, Geleijnse JM, Gans ROB, Bakker SJL, Navis GJ. Fruit and Vegetable Intake and Risk of Posttransplantation Diabetes in Renal Transplant Recipients. Diabetes Care. 2019 Sep;42(9):1645-1652. doi: 10.2337/dc19-0224. Epub 2019 Jul 11.'}, {'pmid': '29464830', 'type': 'DERIVED', 'citation': 'Oste MCJ, Gomes-Neto AW, Corpeleijn E, Gans ROB, de Borst MH, van den Berg E, Soedamah-Muthu SS, Kromhout D, Navis GJ, Bakker SJL. Dietary Approach to Stop Hypertension (DASH) diet and risk of renal function decline and all-cause mortality in renal transplant recipients. Am J Transplant. 2018 Oct;18(10):2523-2533. doi: 10.1111/ajt.14707. Epub 2018 Mar 23.'}, {'pmid': '28978540', 'type': 'DERIVED', 'citation': 'Minovic I, van der Veen A, van Faassen M, Riphagen IJ, van den Berg E, van der Ley C, Gomes-Neto AW, Geleijnse JM, Eggersdorfer M, Navis GJ, Kema IP, Bakker SJ. Functional vitamin B-6 status and long-term mortality in renal transplant recipients. Am J Clin Nutr. 2017 Dec;106(6):1366-1374. doi: 10.3945/ajcn.117.164012. Epub 2017 Oct 4.'}, {'pmid': '28468895', 'type': 'DERIVED', 'citation': 'Minovic I, Riphagen IJ, van den Berg E, Kootstra-Ros JE, van Faassen M, Gomes Neto AW, Geleijnse JM, Gans RO, Eggersdorfer M, Navis GJ, Kema IP, Bakker SJ. Vitamin B-6 deficiency is common and associated with poor long-term outcome in renal transplant recipients. Am J Clin Nutr. 2017 Jun;105(6):1344-1350. doi: 10.3945/ajcn.116.151431. Epub 2017 May 3.'}, {'pmid': '27935524', 'type': 'DERIVED', 'citation': 'Eisenga MF, Kieneker LM, Soedamah-Muthu SS, van den Berg E, Deetman PE, Navis GJ, Gans RO, Gaillard CA, Bakker SJ, Joosten MM. Urinary potassium excretion, renal ammoniagenesis, and risk of graft failure and mortality in renal transplant recipients. Am J Clin Nutr. 2016 Dec;104(6):1703-1711. doi: 10.3945/ajcn.116.134056. Epub 2016 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results. This study is a biobank and cohort study which investigates this hypothesis.', 'detailedDescription': 'Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results.\n\nTo investigate one part of this overarching hypothesis, the investigators wrote a project on around the specific topic of the relation between dietary acid load, ammoniagenesis and its potential influence on blood pressure. The investigators used this project to build a biobank and cohort in which they can test additional hypotheses on the relation between diet, contaminants and development of graft failure and the occurrence of mortality.\n\nThe investigators also included 300 healthy controls to compare diet, contaminant exposure and biomarkers with the renal transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Renal Transplant Recipients and Healthy Potential Kidney Donors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: More than one year after transplantation, prognosis \\> 1 year, stable outpatients situation -\n\nExclusion Criteria: Acute illnesses, fever, current hospitalisation\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02811835', 'acronym': 'TxL-FN', 'briefTitle': 'TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN)', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Renal Sensing of the Acidifying Effect of Sulphur-containing Amino Acids: Consequences for the Relation Between Protein Intake and Blood Pressure in Renal Transplant Recipients', 'orgStudyIdInfo': {'id': 'METc2008/186'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Renal Transplant Recipients', 'description': 'Renal Transplant Recipients that were more than 1 year post-transplantation'}, {'label': 'Healthy Controls', 'description': 'Healthy subjects being evaluated as potential living kidney donors'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Each participant has a study number which is not traceable to the patient in the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'Stephan J.L. Bakker', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}