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

Indiana University logo

Indiana University

Status

Completed

Conditions

Kidney Stones

Treatments

Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol)
Other: 24 hour urine collection
Procedure: Blood draw

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

85 participants in 3 patient groups

Stone Donors
Description:
Evaluation for kidney donation \> 2 years ago, had history of kidney stones or kidney stones on imaging and successfully donated a kidney
Treatment:
Other: 24 hour urine collection
Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol)
Procedure: Blood draw
Denied donors
Description:
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
Treatment:
Other: 24 hour urine collection
Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol)
Procedure: Blood draw
Non-Stone Donors
Description:
Evaluation for kidney donation \> 2 years ago, with no history of kidney stones, or kidney stones on Imaging and successfully donated a kidney
Treatment:
Other: 24 hour urine collection
Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol)
Procedure: Blood draw

Trial contacts and locations

1

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Central trial contact

Mary F Balmes-Fenwick, BS; Gabby E Kline, BS

Data sourced from clinicaltrials.gov

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