Kidney StonesDONATENCT05519150
Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.
An observational study of Kidney Stones, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stones
- What is being tested?
- low dose radiation abdomen/pelvis CT scan (stone protocol), Blood draw and 24 hour urine collection
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2022to 10 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 90 participants who were evaluated to donate a kidney at Indiana University (IU) School of Medicine /IU Health Transplant > 2 years ago.
Who may be able to join
- 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.
Who cannot join
- Subjects who are currently pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health University Hospital
Indianapolis, Indiana, 46202
About this study
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.
Read the 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.
- Conditions
- Kidney Stones
- Being tested
- low dose radiation abdomen/pelvis CT scan (stone protocol), Blood draw, 24 hour urine collection
- Keywords
- transplant
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 drawProcedure or surgery
To compare the changes changes in eGFR in evaluated kidney donors Blood will be draw by a trained phlebotomist.
24 hour urine collectionOther
To compare the changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies in evaluated kidney donors.
| Study group | Role | What they receive |
|---|---|---|
| Stone Donors | Evaluation for kidney donation > 2 years ago, had history of kidney stones or kidney stones on imaging and successfully donated a kidney Receives: 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 Receives: 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 Receives: Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol); Procedure: Blood draw; Other: 24 hour urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: >2 years
Secondary outcomes (2)
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.
Measured: >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.
Measured: >2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start2 Sep 2022
- Primary completion1 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Yahya Jan, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519150
- Sponsor's protocol ID
- 15048
- Acronym
- DONATE
- Status last verified
- Mar 2024
- First submitted
- 26 Aug 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.
- ClinicalTrials.gov ID
- NCT05519150
- Acronym / sponsor ID
- DONATE / 15048
- Conditions
- Kidney Stones
- Keywords
- transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stone Donors | – | Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol), Procedure: Blood draw, Other: 24 hour urine collectionEvaluation for kidney donation > 2 years ago, had history of kidney stones or kidney stones on imaging and successfully donated a kidney |
| Denied donors | – | Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol), Procedure: Blood draw, Other: 24 hour urine collectionEvaluation 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 |
| Non-Stone Donors | – | Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol), Procedure: Blood draw, Other: 24 hour urine collectionEvaluation for kidney donation > 2 years ago, with no history of kidney stones, or kidney stones on Imaging and successfully donated a kidney |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 90 participants who were evaluated to donate a kidney at Indiana University (IU) School of Medicine /IU Health Transplant > 2 years ago.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects who are currently pregnant or breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Diagnostic test | Denied donors, Non-Stone Donors, Stone Donors |
| Blood drawTo compare the changes changes in eGFR in evaluated kidney donors Blood will be draw by a trained phlebotomist. | Procedure or surgery | Denied donors, Non-Stone Donors, Stone Donors |
| 24 hour urine collectionTo compare the changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies in evaluated kidney donors. | Other | Denied donors, Non-Stone Donors, Stone Donors |
Primary outcome
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.
2 secondary outcomes
changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies
Time frame: >2 years
assess formation of new kidney stones by imaging
Time frame: >2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in eGFR and urine protein to urine creatinine ratio (time frame: >2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.