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Completed

NCT Number: NCT05519150

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

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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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Procedure

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

24 hour urine collection

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.

Primary outcomes

  1. changes in eGFR and urine protein to urine creatinine ratio

    Time frame: >2 years

    To 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 outcomes

  1. changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies

    Time frame: >2 years

    To 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.

  2. assess formation of new kidney stones by imaging

    Time frame: >2 years

    To 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: DONATE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2022
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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