RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, with a BMI of ≤ 27 or \>30, with a PRAT thickness measurement of ≥ 14mm or ≤10mm on CT. 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 6 months prior and 6 months after their nephrectomy that includes laboratory findings, CT measurements, vitals, exam data, demographics, medical history and current medications.

Official Title

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

Quick Facts

Study Start:2025-02-10
Study Completion:2028-02-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06886087

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants in this study will be restricted to living kidney transplant donors (LKDs). In order to participate, LKDs must have a BMI that is \<27 kg/m2 or ≥30 kg/m2 and a PRAT measurement score that is \<10 mm or ≥14 mm.
  1. * • Those who do not meet Mayo Clinic Rochester's clinical criterion for donor nephrectomy.
  2. * \>10% weight change between the donor evaluation and donor nephrectomy
  3. * Individuals who have a BMI ≥27 kg/m2 but \<30 kg/m2
  4. * Individuals who are pregnant or are planning to become pregnant
  5. * 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.

Contacts and Locations

Study Contact

Jackie Reiter
CONTACT
507-538-2224
reiter.jacqulyn@mayo.edu
Maulik Lathiya, MBBS
CONTACT
lathiya.maulik@mayo.edu

Principal Investigator

Aleksandra Kukla, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Aleksandra Kukla, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Registration Dates

Study Start Date2025-02-10
Study Completion Date2028-02-10

Study Record Updates

Study Start Date2025-02-10
Study Completion Date2028-02-10

Terms related to this study

Keywords Provided by Researchers

  • healthy volunteers
  • kidney donation

Additional Relevant MeSH Terms

  • Living Kidney Donation
  • Hypertension
  • Nephrectomy