Complications After Hand-Assisted Laparoscopic Living Donor Nephrectomy.
Xiomara Benavides, Richard T Rogers, Ek Khoon Tan...
https://pubmed.ncbi.nlm.nih.gov/35483987Actively Recruiting
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06886087
Prospective Study to Assess the Risks of Perinephric Fat Thickness on Adverse Renal Outcomes Post Donor Nephrectomy - ProActive Study
Led by Mayo Clinic · Updated on 2026-02-17
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether the thickness of perirenal fat (PRAT) is a marker of visceral obesity and how it may affect kidney function and blood pressure in living kidney donors. This observational study focuses on adults aged 18 and older who are scheduled for kidney donation surgery within six months. The goal is to improve future care for managing blood pressure and obesity in these donors by comparing PRAT characteristics between those with low and high PRAT thickness and examining related kidney outcomes. Participants will be grouped based on their PRAT measurement and body mass index (BMI) into either a non-obese or obese group. Samples of blood, urine, and perinephric fat tissue will be collected during the study, including during the kidney removal surgery. The study includes a screening visit, a pre-surgery visit, the day of surgery, and a follow-up visit about six months after donation. Optional 18-hour ambulatory blood pressure monitoring (ABPM) may be performed at some visits. Participants will have their medical history, medications, vital signs, laboratory tests, and imaging data reviewed up to one year before and six months after surgery. Blood and urine samples will be collected for research at multiple visits. Study assessments include blood pressure measurements, weight, height, BMI calculation, and inflammatory markers in the fat tissue. Adverse events will be monitored throughout the study. The total observation period covers from screening until six months post-donation.
CONDITIONS
Brief Title
Assessment of Risks of Perinephric Fat Thickness to Adverse Renal Outcomes Post Donor Nephrectomy
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Participants must be living kidney transplant donors.
- Must be scheduled for donor nephrectomy within 6 months.
- Must meet clinical criteria for kidney donation at the transplant center.
- Age between 18 and 80 years.
- Both male and female participants are eligible.
You will not qualify if you...
- Does not meet clinical criteria for donor nephrectomy.
- More than 10% weight change between donor evaluation and nephrectomy.
- Pregnant or planning to become pregnant.
- Unable to comply with study procedures or conditions that increase risk or affect study outcomes.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 6 months before donor nephrectomy
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for screening and enrollment
Monitoring
Duration - From enrollment until approximately 6 months post-nephrectomy
Participants are monitored through scheduled study visits before, during, and after their donor nephrectomy to collect health data and research samples.
4 visits: Visit 1 before nephrectomy, Visit 2 on nephrectomy day, and Visit 3 approximately 6 months after nephrectomy
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
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Research Team
J
Jackie Reiter
M
Maulik Lathiya, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades.
S J Taler, E E Messersmith, A B Leichtman...
https://pubmed.ncbi.nlm.nih.gov/23137211Renal Function Profile in White Kidney Donors: The First 4 Decades.
Hassan N Ibrahim, Robert N Foley, Scott A Reule...
https://pubmed.ncbi.nlm.nih.gov/26888476Obesity and long-term mortality risk among living kidney donors.
Jayme E Locke, Rhiannon D Reed, Allan B Massie...
https://pubmed.ncbi.nlm.nih.gov/31072668Hypertension after kidney donation: Incidence, predictors, and correlates.
Otto A Sanchez, Laine K Ferrara, Sarah Rein...
https://pubmed.ncbi.nlm.nih.gov/29498216Weight gain after kidney donation: Association with increased risks of type 2 diabetes and hypertension.
Naim Issa, Otto A Sánchez, Aleksandra Kukla...
https://pubmed.ncbi.nlm.nih.gov/30053320Weight trends in living kidney donors suggest predonation counselling alone lacks a sustainable effect on weight loss: a single centre cohort study.
Sai Rithin Punjala, Qainat Adamjee, Lisa Silas...
https://pubmed.ncbi.nlm.nih.gov/33423338Perirenal Fat: A Unique Fat Pad and Potential Target for Cardiovascular Disease.
Bo-Xun Liu, Wei Sun, Xiang-Qing Kong
https://pubmed.ncbi.nlm.nih.gov/30301366Perirenal Fat Promotes Renal Arterial Endothelial Dysfunction in Obese Swine through Tumor Necrosis Factor-α.
Shuangtao Ma, Xiang-Yang Zhu, Alfonso Eirin...
https://pubmed.ncbi.nlm.nih.gov/26417644Endothelial dysfunction and reduced nitric oxide in resistance arteries in autosomal-dominant polycystic kidney disease.
Dan Wang, Jens Iversen, Christopher S Wilcox...
https://pubmed.ncbi.nlm.nih.gov/12969157