Different Vascular and Renal Parameters in Living Kidney Donors

NCT06056466 | Completed

• 1 other identifier: CRC2018Tx
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Renal Injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (20)

• 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

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age of 30 - 85 years
• Male and Female patients
• Persons (evaluated and accepted for kidney donation) in good and stable health condition with eGFR\>60 ml/min/1.73m²
• Informed consent has to be given in written form

You may not qualify if:

• Type-2-diabetes or any other form of diabetes (fasting plasma glucose ≥ 126 mg/dl, HbA1c ≥ 6,5%, post prandial glucose ≥ 200 mg/dl \*
• Uncontrolled arterial hypertension (≥ 180/110 mmHg) \*
• Estimated glomerular filtration rate ≤ 60 ml/min/1.73m² \*
• Significant laboratory abnormalities such as Serum Glutamate-Oxaloacetate-Transaminase (SGOT) or Serum Glutamate-Pyruvate-Transaminase (SGPT) levels more than 3 times above the upper limit of normal range \*
• Patients in unstable conditions due to any kind of serious disease, that infers with the conduction of the trial \*
• Patients suffering from cataract or glaucoma +
• Diabetic retinopathy \*
• active Drug or alcohol abuse \*
• Pregnant and breast-feeding patients \*
• Body mass index \> 33 kg/m² \*
• Participation in another clinical study within 30 days prior to visit 1+
• Subjects who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V +
• For patients undergoing 23Na- and ASL-MRI:
• Implanted pacemakers or defibrillators +
• Other implanted metallic devices, which are not MRI compatible +

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

Related Publications (13)

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  PMID: 27383068 BACKGROUND

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  PMID: 23727165 BACKGROUND

• 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.

  PMID: 23732715 BACKGROUND

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  PMID: 15385656 BACKGROUND

• 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.

  PMID: 15806468 BACKGROUND

• 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.

  PMID: 15037495 BACKGROUND

• 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.

  PMID: 25343954 BACKGROUND

• 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.

  PMID: 2146412 BACKGROUND

• 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.

  PMID: 21885794 BACKGROUND

• 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.

  PMID: 22917703 BACKGROUND

• 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.

  PMID: 6738599 BACKGROUND

• 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.

  PMID: 20226855 BACKGROUND

• 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.

  PMID: 28314581 BACKGROUND

Related Links

• Homepage Clinical Research Center

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: September 28, 2023
• Study Start: May 8, 2019
• Primary Completion: November 30, 2023
• Study Completion: February 15, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)