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

February 13, 2026 updated by: Aleksandra Kukla, Mayo Clinic

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.

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Alexasandra Kukla, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Living kidney donors scheduled for nephrectomy ages 18 - 80

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Non-Obese
Participants with a BMI under 30
Obese
Participants with a BMI greater than or equal to 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proinflammatory Macrophage infiltrations of Perinephric Fat for LKD
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of new or worsening hypertension in LKD
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Aleksandra Kukla, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

February 10, 2027

Study Completion (Estimated)

February 10, 2028

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-006635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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