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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Stones
• Intervention / Treatment: Diagnostic test: low dose radiation abdomen/pelvis CT scan (stone protocol); Procedure: Blood draw; Other: 24 hour urine collection

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.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

90 participants who were evaluated to donate a kidney at Indiana University (IU) School of Medicine /IU Health Transplant > 2 years ago.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stone Donors; Evaluation for kidney donation > 2 years ago, had history of kidney stones or kidney stones on imaging and successfully donated a kidney	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.
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	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.
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in eGFR and urine protein to urine creatinine ratio	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.	>2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies	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 years
assess formation of new kidney stones by imaging	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.	>2 years

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: transplant
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 15048 (Other Grant/Funding Number: Kazakh Academy of Nutrition)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No