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

NCT05519150 | Completed

• 1 other identifier: 15048
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stones

Keywords

transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  >2 years

• assess formation of new kidney stones by imaging

  >2 years

Study Arms (3)

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); Procedure: Blood draw; Other: 24 hour urine collection

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); Procedure: Blood draw; Other: 24 hour urine collection

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); Procedure: Blood draw; Other: 24 hour urine collection

Interventions

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).

Denied donors; Non-Stone Donors; Stone Donors

Blood draw PROCEDURE

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

Denied donors; Non-Stone Donors; Stone Donors

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.

Denied donors; Non-Stone Donors; Stone Donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects who are currently pregnant or breast feeding.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: September 2, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 10, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

US (1)