Assessment of Risks of Perinephric Fat Thickness to Adverse Renal Outcomes Post Donor Nephrectomy

NCT06886087 | Recruiting

• 1 other identifier: 24-006635
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn if PRAT thickness is a marker of visceral obesity and its influence on donors' kidney function and blood pressure in living kidney donors. Population includes male/female, 18 years and up, living kidney donors scheduled for nephrectomy within 6 months. The main area it aims to help in, is future care managing blood pressure and obesity in living kidney transplant donors. Primary Hypothesis: We hypothesize that Perirenal Fat Thickness (PRAT) may exhibit expansion, remodeling and inflammation that can negatively affect renal outcomes in LKDs. Researchers will compare PRAT morphology and inflammation in LKDs with low and high PRAT thickness. We will also correlate PRAT thickness with renal outcomes including vascular remodeling, at the time of donation and worsening hypertension and inadequately increased compensatory GFR of the LKD at 4-6 months post-donation. Participants will be separated into one of two groups depending on their PRAT measurement and asked to give samples of their blood, perinephric fat, and urine as research samples. Clinically we will abstract data up to 12 months prior and 6 months after their nephrectomy that includes laboratory findings, CT measurements, vitals, exam data, demographics, medical history and current medications.

Conditions

Living Kidney Donation; Hypertension; Nephrectomy

Keywords

healthy volunteers; kidney donation

Outcome Measures

Primary Outcomes (1)

• Proinflammatory Macrophage infiltrations of Perinephric Fat for LKD

  Compare Living Kidney Donors total PRAT thickness with incidence of increased macrophages between the two groups in the study reported as a ratio between proinflammatory and anti-inflammatory and calculated to a percentage.

  12 months

Secondary Outcomes (1)

• Development of new or worsening hypertension in LKD

  12 months

Study Arms (2)

Non-Obese

Participants with a BMI under 30

Obese

Participants with a BMI greater than or equal to 30

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Living kidney donors scheduled for nephrectomy ages 18 - 80

You may qualify if:

• Participants in this study will be restricted to living kidney transplant donors (LKDs). .

You may not qualify if:

• Those who do not meet Mayo Clinic Rochester's clinical criterion for donor nephrectomy.
• \>10% weight change between the donor evaluation and donor nephrectomy
• Individuals who are pregnant or are planning to become pregnant
• Inability to comply with study procedures or any condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (10)

• Benavides X, Rogers RT, Tan EK, Merzkani MA, Thirunavukkarasu S, Yigitbilek F, Smith BH, Rule AD, Kukla A, Chow GK, Heimbach JK, Taner T, Dean PG, Prieto M, Stegall MD. Complications After Hand-Assisted Laparoscopic Living Donor Nephrectomy. Mayo Clin Proc. 2022 May;97(5):894-904. doi: 10.1016/j.mayocp.2021.11.023. Epub 2022 Apr 25.

  PMID: 35483987 BACKGROUND

• Taler SJ, Messersmith EE, Leichtman AB, Gillespie BW, Kew CE, Stegall MD, Merion RM, Matas AJ, Ibrahim HN; RELIVE Study Group. Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades. Am J Transplant. 2013 Feb;13(2):390-8. doi: 10.1111/j.1600-6143.2012.04321.x. Epub 2012 Nov 8.

  PMID: 23137211 BACKGROUND

• Ibrahim HN, Foley RN, Reule SA, Spong R, Kukla A, Issa N, Berglund DM, Sieger GK, Matas AJ. Renal Function Profile in White Kidney Donors: The First 4 Decades. J Am Soc Nephrol. 2016 Sep;27(9):2885-93. doi: 10.1681/ASN.2015091018. Epub 2016 Feb 17.

  PMID: 26888476 BACKGROUND

• Locke JE, Reed RD, Massie AB, MacLennan PA, Sawinski D, Kumar V, Snyder JJ, Carter AJ, Shelton BA, Mustian MN, Lewis CE, Segev DL. Obesity and long-term mortality risk among living kidney donors. Surgery. 2019 Aug;166(2):205-208. doi: 10.1016/j.surg.2019.03.016. Epub 2019 May 7.

  PMID: 31072668 BACKGROUND

• Sanchez OA, Ferrara LK, Rein S, Berglund D, Matas AJ, Ibrahim HN. Hypertension after kidney donation: Incidence, predictors, and correlates. Am J Transplant. 2018 Oct;18(10):2534-2543. doi: 10.1111/ajt.14713. Epub 2018 Apr 6.

  PMID: 29498216 BACKGROUND

• Issa N, Sanchez OA, Kukla A, Riad SM, Berglund DM, Ibrahim HN, Matas AJ. Weight gain after kidney donation: Association with increased risks of type 2 diabetes and hypertension. Clin Transplant. 2018 Sep;32(9):e13360. doi: 10.1111/ctr.13360. Epub 2018 Aug 18.

  PMID: 30053320 BACKGROUND

• Punjala SR, Adamjee Q, Silas L, Gokmen R, Karydis N. Weight trends in living kidney donors suggest predonation counselling alone lacks a sustainable effect on weight loss: a single centre cohort study. Transpl Int. 2021 Mar;34(3):514-524. doi: 10.1111/tri.13816. Epub 2021 Feb 3.

  PMID: 33423338 BACKGROUND

• Liu BX, Sun W, Kong XQ. Perirenal Fat: A Unique Fat Pad and Potential Target for Cardiovascular Disease. Angiology. 2019 Aug;70(7):584-593. doi: 10.1177/0003319718799967. Epub 2018 Oct 9.

  PMID: 30301366 BACKGROUND

• Ma S, Zhu XY, Eirin A, Woollard JR, Jordan KL, Tang H, Lerman A, Lerman LO. Perirenal Fat Promotes Renal Arterial Endothelial Dysfunction in Obese Swine through Tumor Necrosis Factor-alpha. J Urol. 2016 Apr;195(4 Pt 1):1152-9. doi: 10.1016/j.juro.2015.08.105. Epub 2015 Sep 28.

  PMID: 26417644 BACKGROUND

• Wang D, Iversen J, Wilcox CS, Strandgaard S. Endothelial dysfunction and reduced nitric oxide in resistance arteries in autosomal-dominant polycystic kidney disease. Kidney Int. 2003 Oct;64(4):1381-8. doi: 10.1046/j.1523-1755.2003.00236.x.

  PMID: 12969157 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, fat and urine

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aleksandra Kukla, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Reiter

CONTACT

507-538-2224; reiter.jacqulyn@mayo.edu

Maulik Lathiya, MBBS

CONTACT

lathiya.maulik@mayo.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrology

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: March 20, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): February 10, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)