RightFit
RecruitingPhase not listed

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit, 3 visits, 2 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "6.1 Screening Visit Patients who have had their donor nephrectomy scheduled will be approached for enrollment."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether the thickness of fat around a kidney is linked to kidney function and blood pressure after kidney donation. It is for living kidney donors age 18 or older who plan to have surgery to remove a kidney within 6 months. Researchers will compare donors with thinner and thicker layers of fat around their kidneys.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a living kidney donor.
  • You are age 18 or older.
  • You are scheduled for surgery to remove a kidney within 6 months.

Who can't join

  • You do not meet Mayo Clinic Rochester's medical rules for kidney donation surgery.
  • Your weight changes by more than 10% between your donor checkup and surgery.
  • You are pregnant or plan to become pregnant.
  • You cannot follow the study steps.
  • The study doctor thinks you have a condition that could make the study less safe for you or affect the study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MN