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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-02

Study Completion Date

2023-10-10

Brief Summary

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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.

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Detailed Description

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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

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Kidney Stones

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stone Donors

Evaluation for kidney donation \> 2 years ago, had history of kidney stones or kidney stones on imaging and successfully donated a kidney

low dose radiation abdomen/pelvis CT scan (stone protocol)

Intervention Type DIAGNOSTIC_TEST

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).

Blood draw

Intervention Type PROCEDURE

To compare the changes changes in eGFR in evaluated kidney donors Blood will be draw by a trained phlebotomist.

24 hour urine collection

Intervention Type OTHER

To compare the changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies in evaluated kidney donors.

Denied donors

Evaluation for kidney donation \> 2 years ago, had history of kidney stones or kidney stones on imaging and were declined for donation due to history of kidney stones, Litholink abnormalities or Imaging findings

low dose radiation abdomen/pelvis CT scan (stone protocol)

Intervention Type DIAGNOSTIC_TEST

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).

Blood draw

Intervention Type PROCEDURE

To compare the changes changes in eGFR in evaluated kidney donors Blood will be draw by a trained phlebotomist.

24 hour urine collection

Intervention Type OTHER

To compare the changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies in evaluated kidney donors.

Non-Stone Donors

Evaluation for kidney donation \> 2 years ago, with no history of kidney stones, or kidney stones on Imaging and successfully donated a kidney

low dose radiation abdomen/pelvis CT scan (stone protocol)

Intervention Type DIAGNOSTIC_TEST

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).

Blood draw

Intervention Type PROCEDURE

To compare the changes changes in eGFR in evaluated kidney donors Blood will be draw by a trained phlebotomist.

24 hour urine collection

Intervention Type OTHER

To compare the changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies in evaluated kidney donors.

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Blood draw

To compare the changes changes in eGFR in evaluated kidney donors Blood will be draw by a trained phlebotomist.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18,
* Evaluation for kidney donation \> 2 years ago, with A) no history of kidney stones, or kidney stones on Imaging and successfully donated a kidney B) either had history of kidney stones or kidney stones on imaging and either i) successfully donated a kidney or ii) were declined for donation due to history of kidney stones, Litholink abnormalities or Imaging findings
* Willing to participate and sign an informed consent.