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A Prospective, Observational, Non-interventional, Single-center Study to Analyze the Relationship Between Different Vascular and Renal Parameters in Living Kidney Donors With 1 Year Follow-up
Sponsor study identifier
observational
25
1 country
1
Study Start
May 8, 2019
Actual (reported)Primary Completion
November 30, 2023
Actual (reported)Study Completion
February 15, 2024
Actual (reported)Chronic kidney disease (CKD) has a high prevalence globally and is a global health concern. CKD is associated with increased risks of cardiovascular morbidity, mortality and therefore decreased quality of life in any stage of the disease. CKD in early stage is often asymptomatic, which makes the detection of the disease difficult. In this study our goal is to analyze in a clinical trial to what extend renal and vascular parameters correlate with histological kidney changes, especially in a population with eGFR rate of more than 60 mL/min/1.73 m² or pseduonormalized renal function. Our crossectional analysis focus on the association of abnormal vascular and renal parameters with histological renal changes. Our longitudinal analysis focus on the association of histological with renal and/or vascular parameters at baseline, with the renal outcome after kidney donation. Different renal and vascular parameters are obtained non-invasively in potential living kidney donors before donation. Preimplantation kidney biopsies are obtained routinely during donation, which is a standard procedure of our living kidney donation programme. The living kidney donors will be followed up in respect to renal function and blood pressure for one year after donation. Our hypothesis is that histological scoring of renal damage (total renal chronicity scores) correlates with vascular parameters indicating increased stiffness. The primary vascular parameter is wall to lumen ratio of retinal arterioles. Moreover the investigators hypothesize that vascular parameters predicts 24-hour blood pressure and renal outcome (eGFR, albuminuria) one year after donation. To prove this hypothesis overall the investigators will include 25 subjects in this study, having been evaluated before as potential living kidney donors. Total duration of this study for each volunteer is 15 months with total 5 visits, of which 4 are at the Clinical Research Unit (CRC) of the Department of Nephrology, University of Erlangen-Nuremberg and one is the day of kidney donation. This study is important to detect renal damage or CKD in patients with eGFR rate of more than 60 mL/min/1.73 m² or pseduonormalized renal function (CKD stage 1 or 2).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 8, 2019
Actual (reported)July 14, 2023
Actual (reported)September 28, 2023
Actual (reported)November 30, 2023
Actual (reported)February 15, 2024
Actual (reported)Wall to lumen ratio of retinal arterioles assessed by SLDF
The primary objective of the study is to analyze wall to lumen ratio of retinal arterioles before kidney donation and 6 months after donation
within 8 weeks before donation, 6 months after donation
Retinal capillary flow determined by SLDF measurement
within 8 weeks before donation, 6 months after donation
Central systolic pressure assessed by Sphygmocor XCEL
within 8 weeks before donation, 6 months after donation
Pulse pressure assessed by Sphygmocor XCEL
within 8 weeks before donation, 6 months after donation
Pulse wave velocity assessed by Sphygmocor XCEL
within 8 weeks before donation, 6 months after donation
Augmentation index assessed by Sphygmocor XCEL
within 8 weeks before donation, 6 months after donation
Participants will be recruited from the transplantion center of Erlangen-Nuremberg, Germany. Eligible participants will be screened according to the inclusion and exclusion criteria on Visit 1 after approval of donation by immunological, psychological, medical evaluation and positive vote of the living donation commission.
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
Erlangen, 91054, Germany
Hill NR, Fatoba ST, Oke JL, Hirst JA, O'Callaghan CA, Lasserson DS, Hobbs FD. Global Prevalence of Chronic Kidney Disease - A Systematic Review and Meta-Analysis. PLoS One. 2016 Jul 6;11(7):e0158765. doi: 10.1371/journal.pone.0158765. eCollection 2016.
Eckardt KU, Coresh J, Devuyst O, Johnson RJ, Kottgen A, Levey AS, Levin A. Evolving importance of kidney disease: from subspecialty to global health burden. Lancet. 2013 Jul 13;382(9887):158-69. doi: 10.1016/S0140-6736(13)60439-0. Epub 2013 May 31.
25 participants (actual enrollment reported by the registry).
First Submitted
July 14, 2023
First Posted
September 28, 2023
Study Start
May 8, 2019
Actual (reported)Contact the study team to confirm eligibility.
Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.
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Perlman RL, Finkelstein FO, Liu L, Roys E, Kiser M, Eisele G, Burrows-Hudson S, Messana JM, Levin N, Rajagopalan S, Port FK, Wolfe RA, Saran R. Quality of life in chronic kidney disease (CKD): a cross-sectional analysis in the Renal Research Institute-CKD study. Am J Kidney Dis. 2005 Apr;45(4):658-66. doi: 10.1053/j.ajkd.2004.12.021.
Keith DS, Nichols GA, Gullion CM, Brown JB, Smith DH. Longitudinal follow-up and outcomes among a population with chronic kidney disease in a large managed care organization. Arch Intern Med. 2004 Mar 22;164(6):659-63. doi: 10.1001/archinte.164.6.659.
Park M, Yoon E, Lim YH, Kim H, Choi J, Yoon HJ. Renal hyperfiltration as a novel marker of all-cause mortality. J Am Soc Nephrol. 2015 Jun;26(6):1426-33. doi: 10.1681/ASN.2014010115. Epub 2014 Oct 24.
Schmieder RE, Messerli FH, Garavaglia G, Nunez B. Glomerular hyperfiltration indicates early target organ damage in essential hypertension. JAMA. 1990 Dec 5;264(21):2775-80.
Maeda I, Hayashi T, Sato KK, Koh H, Harita N, Nakamura Y, Endo G, Kambe H, Fukuda K. Cigarette smoking and the association with glomerular hyperfiltration and proteinuria in healthy middle-aged men. Clin J Am Soc Nephrol. 2011 Oct;6(10):2462-9. doi: 10.2215/CJN.00700111. Epub 2011 Sep 1.
Melsom T, Mathisen UD, Eilertsen BA, Ingebretsen OC, Jenssen T, Njolstad I, Solbu MD, Toft I, Eriksen BO. Physical exercise, fasting glucose, and renal hyperfiltration in the general population: the Renal Iohexol Clearance Survey in Tromso 6 (RENIS-T6). Clin J Am Soc Nephrol. 2012 Nov;7(11):1801-10. doi: 10.2215/CJN.02980312. Epub 2012 Aug 23.
Mogensen CE, Christensen CK. Predicting diabetic nephropathy in insulin-dependent patients. N Engl J Med. 1984 Jul 12;311(2):89-93. doi: 10.1056/NEJM198407123110204.
Benz K, Amann K. Maternal nutrition, low nephron number and arterial hypertension in later life. Biochim Biophys Acta. 2010 Dec;1802(12):1309-17. doi: 10.1016/j.bbadis.2010.03.002. Epub 2010 Mar 10.
Sethi S, D'Agati VD, Nast CC, Fogo AB, De Vriese AS, Markowitz GS, Glassock RJ, Fervenza FC, Seshan SV, Rule A, Racusen LC, Radhakrishnan J, Winearls CG, Appel GB, Bajema IM, Chang A, Colvin RB, Cook HT, Hariharan S, Herrera Hernandez LP, Kambham N, Mengel M, Nath KA, Rennke HG, Ronco P, Rovin BH, Haas M. A proposal for standardized grading of chronic changes in native kidney biopsy specimens. Kidney Int. 2017 Apr;91(4):787-789. doi: 10.1016/j.kint.2017.01.002.
Primary Completion
November 30, 2023
Actual (reported)Study Completion
February 15, 2024
Actual (reported)Last Updated
August 14, 2024
Record last verified: 2024-08
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