NCT05519150

Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

We believe that kidney donors with kidney stones accepted for a donation do not have an increased risk of loss of kidney function and will not be at increased risk of symptomatic kidney stone events compared to donors without a history of kidney stones.

Detailed description

Indiana University Health center has a large nephrology and transplant service which is well versed in taking care of kidney donors with history of kidney stones. We believe that kidney donors with kidney stones accepted for a donation do not have an increased risk of loss of kidney function and will not be at increased risk of symptomatic kidney stone events compared to donors without a history of kidney stones. In this study we are contacting past kidney donors and participants with kidney stone who were declined as kidney donors. We will use blood tests, 24-hour urine tests, computed tomography (CT) scan, patient reported medical history and medical history in the patient's chart to gather data. This data will help us compare non stone donors, stone donors, and participants with kidney stone who were declined as kidney donors.

Conditions

• Kidney Stones

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	low dose radiation abdomen/pelvis CT scan (stone protocol)	Kidney donors who consent will undergo a low dose radiation abdominal CT scan to identify new kidney stones in the remaining kidney. The will come to an IU Health Hospital for a low dose radiation abdomen/pelvis CT scan (stone protocol).
PROCEDURE	Blood draw	To compare the changes changes in eGFR in evaluated kidney donors Blood will be draw by a trained phlebotomist.
OTHER	24 hour urine collection	To compare the changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies in evaluated kidney donors.

Timeline

• Start date: 2022-09-02
• Primary completion: 2023-10-01
• Completion: 2023-10-10
• First posted: 2022-08-29
• Last updated: 2024-03-05

Locations

1 site across 1 country: United States