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Living Kidney DonationProActiveNCT06886087

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

An observational study of Living Kidney Donation and Hypertension, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Living Kidney Donation, Hypertension, Nephrectomy
How many people
100 participants
Where
1 siteUnited States
Study dates
10 Feb 2025to 10 Feb 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Living kidney donors scheduled for nephrectomy ages 18 - 80

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maulik Lathiya, MBBS contact

lathiya.maulik@mayo.edu

United States1 site, 1 recruiting
  • Mayo Clinic

    Rochester, Minnesota, 55905

    Jackie Reiter, 507-538-2224, REITER.JACQULYN@MAYO.EDU

    Alexasandra Kukla, MD

    Recruiting

Other trials in United States

About this study

Official title: Prospective Study to Assess the Risks of Perinephric Fat Thickness on Adverse Renal Outcomes Post Donor Nephrectomy - ProActive Study

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.

Read more

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.

Read the detailed description

6.1 Screening Visit Patients who have had their donor nephrectomy scheduled will be approached for enrollment. Potential participants must preliminarily meet all inclusion and no exclusion criteria to be approached by a study team member about study participation. If there is 10% (or greater) weight loss between the clinical donor evaluation visit and the potential screening visit the individual will not be approached for enrollment.

If all required inclusion and no exclusion criterion are met, the study team will present the consent form to the potential participant.

After the consent form has been signed, the following study procedures will be performed at the screening visit:

  • The following information will be collected study team member will review the participant's demographic information, m The following information will be recorded from the participant's from their electronic medical record
  • Participant's demographic information
  • Medical history and current medications and, if needed, ask the participant clarifying questions
  • Pregnancy test results (if applicable)
  • Current medications
  • Most recent weight
  • Height
  • BMI
  • Clinical Donor Evaluation
  • PRAT Measurement
  • The following lab results will also be collected from the medical record
  • Creatinine with eGFR
  • Comprehensive Metabolic Panel Glucose
  • Fasting Lipid Profile
  • HbA1c
  • 24-hour Urine for Albumin Excretion
  • An 18-hour ABPM may be completed with subject consent at either the Screening Visit or Visit 1 if (if it has not been obtained clinically 6 months prior to the scheduled donor nephrectomy) or there has been a clinically significant blood pressure medication changes. A sphygmomanometry measurement will be collected at each visit unless the 18-hour ABPM is performed.

Serious adverse events will also be recorded and addressed as applicable at every study visit after the participant signs consent. All adverse events will be recorded from Visit 2 until the subject completes or is withdrawn from the study.

In applicable situations (i.e., the subject does not need to be seen in person to complete all study procedures) the screening visit can be completed remotely.

After this information has been collected, participants will be categorized into 1 of the 2 groups based upon their PRAT measurement and BMI. If the PRAT thickness or the BMI does not meet study criterion, the participant will be considered a screen failure.

6.2 Visit 1

During this visit, the following study procedures will also occur:

  • The study team will record the following information from the medical record:
  • Changes in the participant's medical history or medications.
  • Participant's current weight and height.
  • Participant's BMI
  • 10 mL of blood and 50mL urine will also be collected for research purposes.
  • An optional 18-hour ABPM may be completed if the subject has consented to this procedure and it was not collected during the screening visit. If a subject declines the 18-hour ABPM a sphygmomanometry measurement will be collected.

6.3 Visit 2

Visit 2 will occur the day of the living kidney donor's nephrectomy. During this visit, the study team will perform the following:

  • Record the following information from the participant's medical record:
  • changes to the medical history or medications.
  • The participant's current weight and height
  • Participant's BMI
  • Information on the nephrectomy.
  • Hemoglobin
  • 24-hour ABPM
  • During the nephrectomy, the study team will collect a 5-10g fat sample for research analysis.

6.5 Visit 3

This visit will take place approximately 6 months after the donor nephrectomy. During this visit, the study team will:

  • Record the following information from the EMR:
  • Any changes to the participant's medical history or medications.
  • The participant's current weight and, height.
  • Current BMI
  • The participant's blood pressure, via sphygmomanometry.
  • Creatinine with eGFR
  • Fasting Lipid Profile
  • Glucose
  • An 18-hour APBM will be completed with participant consent and if it was not completed as a part of clinical care. If a subject declines the 18-hour ABPM a 6h AMBP monitoring performed clinically will be collected
  • 10 mL of blood and 50 mL of urine will be collected for research purposes.
Keywords
healthy volunteers, kidney donation
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06886087
Study groupRoleWhat they receive
Non-ObeseParticipants with a BMI under 30
ObeseParticipants with a BMI greater than or equal to 30

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (1)
  1. Development of new or worsening hypertension in LKD

    Compare Living Kidney Donors total PRAT thickness with incidence of new or worsening hypertension as defined by a blood pressure of >140/90 mm Hg

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start10 Feb 2025
  3. Primary completion10 Feb 2027 (estimated)
  4. Study completion10 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06886087
Sponsor's protocol ID
24-006635
Acronym
ProActive
Status last verified
Feb 2026
First submitted
5 Feb 2025
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35483987
  • 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.

    PubMed 23137211
  • 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.

    PubMed 26888476
  • 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.

    PubMed 31072668
  • 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.

    PubMed 29498216
  • 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.

    PubMed 30053320
  • 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.

    PubMed 33423338
  • 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.

    PubMed 30301366
  • 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.

    PubMed 26417644
  • 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.

    PubMed 12969157

Questions about this trial

What is this clinical trial studying?

An observational study of Living Kidney Donation and Hypertension, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jackie Reiter (507-538-2224, reiter.jacqulyn@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proinflammatory Macrophage infiltrations of Perinephric Fat for LKD (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06886087, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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