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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05519150
Acronym
DONATE
Enrollment
85
Registered
2022-08-29
Start date
2022-09-02
Completion date
2023-10-10
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stones

Keywords

transplant

Brief 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.

Interventions

DIAGNOSTIC_TESTlow 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).

PROCEDUREBlood draw

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

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

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

* Subjects who are currently pregnant or breast feeding.

Design outcomes

Primary

MeasureTime frameDescription
changes in eGFR and urine protein to urine creatinine ratio>2 yearsTo assess the changes in eGFR and urine protein to urine creatinine ratio in kidney donors with history of kidney stones who donated a kidney 2 or more years ago. We will compare these kidney donors with the age, sex, years since donation and body mass index matched standard (non-stone) kidney donors for absolute eGFR and protein/creatinine urine ratio change, using time as a denominator by paired t-test.

Secondary

MeasureTime frameDescription
changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies>2 yearsTo compare the changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies in kidney donors with history of kidney stones compared to those who were rejected for donation due to abnormal urine studies or CT scan. We will compare pre-post 24-hour urine results for supersaturation of calcium oxalate, calcium phosphate, and uric acid (composite risks), and the individual parameters of urine volume, calcium, citrate, oxalate, uric acid and pH with paired t-test.
assess formation of new kidney stones by imaging>2 yearsTo assess formation of new kidney stones by imaging. Kidney donors who consent will undergo a low dose radiation abdominal CT scan to identify new kidney stones in the remaining kidney. We will determine the number of symptomatic, passed, and asymptomatic kidney stones on CT scan post donation as a function of time.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026