NCT06886087 Assessment of Risks of Perinephric Fat Thickness to Adverse Renal Outcomes Post Donor Nephrectomy
| NCT ID | NCT06886087 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Living Kidney Donation |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2027-02-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-02-10 with a primary completion date of 2027-02-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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.
Contact & Investigator
Aleksandra Kukla, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06886087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Living Kidney Donation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06886087 currently recruiting?
Yes, NCT06886087 is actively recruiting participants. Contact the research team at reiter.jacqulyn@mayo.edu for enrollment information.
Where is the NCT06886087 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06886087 clinical trial?
NCT06886087 is sponsored by Mayo Clinic. The principal investigator is Aleksandra Kukla, MD at Mayo Clinic. The trial plans to enroll 100 participants.
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