Renal Transplant Donor of Left KidneyNCT04810884
Fractures and Bone Disease in Living Kidney Donors
An observational study of Renal Transplant Donor of Left Kidney and Renal Transplant Donor of Right Kidney, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being done to measure bone health in living kidney donors and compare them to non-kidney donors to learn if living kidney donors have a higher risk of bone fractures (breaks) after kidney donation. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Renal Transplant Donor of Left Kidney, Renal Transplant Donor of Right Kidney
- How many people
- 4,415 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 4 Aug 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 50 years and older
- All sexes
- Adult, Older adult
Study population: Living kidney donors who are more than 10 years post donation and who are 50 years of age or older at the time of study enrollment and matched controls.
Who may be able to join
- Aim 1: Survey (Donors):
- Donated a kidney at one of the three participating sites.
- 10 or more years have passed since donation.
- Age ≥ 50 at time of study enrollment.
- Aim 1: Survey (Controls):
- Subjects in the REP population.
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- Medical records available for the five years preceding age at matching (age at donation).
- Matching will be based on: age, year of donation, sex, race/ethnicity, body mass index, comorbidity and selected risk factors (smoking, education level) status at year of donation
- Aim 2: Skeletal health assessment (Donors and Controls):
- Subjects who have completed the survey
- Willing to come in for the in-person assessment
Who cannot join
- Aim 1: Survey (Donors):
- Deceased
- Not willing to return the survey.
- Aim 1: Survey (Controls):
- Deceased
- Not willing to return the survey
Show all 12Show fewer
- History of the following conditions:
- Diabetes mellitus, liver disease, kidney disease, nephrolithiasis, malabsorption syndrome, past history of non-traumatic fractures.
- Aim 2: Skeletal health assessment (Donors and Controls):
- Subjects who did not participate in the survey
- Subjects not willing to come for the in-person evaluation.
- Women of childbearing potential.
Trial locations and contacts
1 site in 1 country.
About this study
This research study is being done to measure bone health in living kidney donors and compare them to non-kidney donors to learn if living kidney donors have a higher risk of bone fractures (breaks) after kidney donation. Certain chemicals in the body that help maintain bone health were shown to have changed after kidney donation in living donors, whether or not these changes lead to a decrease in bone quality and increase the risk of fractures is not known.
The purpose of this study is to compare the bone health of living kidney donors, with the bone health of non-kidney donors. This information will be helpful in informing future kidney donors of the risks of donation and in creating treatments to help prevent these complications.
Read the detailed description
This is an observational study that consists of two Aims:
Aim 1 is a survey sent to 3000 prior living kidney donors and 3000 matched controls. The survey contains questions about history of bone fractures and general bone health. Prior living kidney donors will be identified and surveyed from three Minnesota centers: Mayo Clinic, Rochester; Hennepin County Medical Center (HCMC); and the University of Minnesota (UMN).
Aim 2 of this study includes an assessment of bone structure and bone turnover markers in a subset of donors and matched controls. 200 prior living kidney donors and 200 matched controls will be invited to Mayo Clinic Rochester's CRTU for an assessment of bone health. Each subject will undergo lateral DXA with VFA assessment, bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment(µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Living kidney donors | Aim 1: A survey about fractures and general bone health will be sent to 3000 prior living kidney donors. Aim 2: Out of these 3000 subjects, 200 prior living kidney donors who are ≥10 years post kidney donation will be invited to Mayo Clinic Rochester for an assessment of bone health. Each subject will undergo lateral DXA with vertebral fracture assessment (VFA), bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment (µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption. | |
| Matched Controls | Aim 1: A survey about fractures and general bone health will be sent to 3000 age, sex, race, and comorbidity-matched subjects who would have been eligible to donate but did not donate a kidney. Aim 2: Out of these 3000 subjects, 200 control subjects who would be eligible to donate, but have not donated, and are matched by age, sex, race, and comorbidity to donors at the time of donation will be invited to Mayo Clinic Rochester for an assessment of bone health. Each subject will undergo lateral DXA with vertebral fracture assessment (VFA), bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment (µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate bone health and bone fracture incidence in kidney donors and non-kidney donors
Measured by participant self-report response to survey about bone fractures and bone health survey
Measured: Baseline
Changes in bone health after kidney donation
As indicated by comparisons between kidney donors and non-donors of dual-energy X-ray absorptiometry (DXA) measurements of bone mineral density at the lumbar spine (L1-L4), total hip and distal 1/3 of the forearm (GE Lunar) by DXA. Will be expressed as a T-score offset from expected peak bone mass as contained in the DXA scanner manufacturers' database.
Measured: Day 1
Incidence of differences in bone architecture and strength after kidney donation
By comparisons of kidney donors and non-donors in measures of volumetric density and bone microarchitecture at the distal radius and tibia by high-resolution peripheral quantitative computed tomography (HR-pQCT). Bone strength will be evaluated using Image Processing Language (IPL) software to generate microfinite element (μFE) models from HR-pQCT imaging.
Measured: Day 1
Incidence of changes in blood counts and blood chemistry measures after kidney donation
Based on variations between donors and non-donors in measures of complete blood count, serum electrolytes, Ca, Pi, creatinine, blood urea nitrogen and albumin.
Measured: Day 1
Assess the correlations of bone biomarker and serum hormone concentrations with bone mineral density.
Based on comparison of bone and serum biomarkers in kidney donors and non-donors: (NTX; CTX; TRAcP5b; OC; BAP; P1NP; sclerostin assay); 1,25(OH)2D; 25(OH)D2 and 25(OH)D3; parathyroid hormone (PTH); fibroblast growth factor-23 (FGF23).
Measured: Day 1
Assess the correlations of renal function with bone mineral health.
Renal function will be assessed by Measured Glomerular Filtration Rate (GFR), using the iothalamate short renal clearance technique, and by 24 hour urine collection to record the measures of creatinine clearance, urinary excretion of calcium, phosphorus, albumin and protein.
Measured: Day 1
Secondary outcomes (2)
Explore how vertebral Trabecular Bone Score (TBS) correlates with measures of bone health.
Trabecular bone score (TBS), a measure of bone quality, will be assessed from existing DXA images.
Measured: Day 1
Evaluate Advanced Glycation Endproducts (AGEs) correlation to bone health parameters.
The AGEs Reader will measure the accumulations of AGEs in tissues in kidney donors and controls.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start25 Jun 2020
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant Donor of Left KidneyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 4,415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajiv Kumar, M.D., Mayo Clinic
- Investigators
- Rajiv Kumar, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810884
- Sponsor's protocol ID
- 20-004432
- Other IDs
- R01DK125252
- Status last verified
- Oct 2023
- First submitted
- 15 Feb 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractures and Bone Disease in Living Kidney Donors
- ClinicalTrials.gov ID
- NCT04810884
- Acronym / sponsor ID
- 20-004432
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,415 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 23 Mar 2021 (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.
This research study is being done to measure bone health in living kidney donors and compare them to non-kidney donors to learn if living kidney donors have a higher risk of bone fractures (breaks) after kidney donation. Certain chemicals in the body that help maintain bone health were shown to have changed after kidney donation in living donors, whether or not these changes lead to a decrease in bone quality and increase the risk of fractures is not known.
The purpose of this study is to compare the bone health of living kidney donors, with the bone health of non-kidney donors. This information will be helpful in informing future kidney donors of the risks of donation and in creating treatments to help prevent these complications.
Detailed description
This is an observational study that consists of two Aims:
Aim 1 is a survey sent to 3000 prior living kidney donors and 3000 matched controls. The survey contains questions about history of bone fractures and general bone health. Prior living kidney donors will be identified and surveyed from three Minnesota centers: Mayo Clinic, Rochester; Hennepin County Medical Center (HCMC); and the University of Minnesota (UMN).
Aim 2 of this study includes an assessment of bone structure and bone turnover markers in a subset of donors and matched controls. 200 prior living kidney donors and 200 matched controls will be invited to Mayo Clinic Rochester's CRTU for an assessment of bone health. Each subject will undergo lateral DXA with VFA assessment, bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment(µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Living kidney donors | – | –Aim 1: A survey about fractures and general bone health will be sent to 3000 prior living kidney donors. Aim 2: Out of these 3000 subjects, 200 prior living kidney donors who are ≥10 years post kidney donation will be invited to Mayo Clinic Rochester for an assessment of bone health. Each subject will undergo lateral DXA with vertebral fracture assessment (VFA), bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment (µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption. |
| Matched Controls | – | –Aim 1: A survey about fractures and general bone health will be sent to 3000 age, sex, race, and comorbidity-matched subjects who would have been eligible to donate but did not donate a kidney. Aim 2: Out of these 3000 subjects, 200 control subjects who would be eligible to donate, but have not donated, and are matched by age, sex, race, and comorbidity to donors at the time of donation will be invited to Mayo Clinic Rochester for an assessment of bone health. Each subject will undergo lateral DXA with vertebral fracture assessment (VFA), bone density assessment of each hip, radius and spine by DXA scan, bone structure assessment by HRpQCT of the distal radius and tibia, finite element assessment (µFEA), skin AGEs measurement, and blood collection to measure markers of bone formation and resorption. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Living kidney donors who are more than 10 years post donation and who are 50 years of age or older at the time of study enrollment and matched controls.
Key inclusion criteria (11 listed)
- Donated a kidney at one of the three participating sites.
- 10 or more years have passed since donation.
- Age ≥ 50 at time of study enrollment.
- Subjects in the REP population.
- Medical records available for the five years preceding age at matching (age at donation).
Key exclusion criteria (12 listed)
- Deceased
- Not willing to return the survey.
- Deceased
- Not willing to return the survey
- History of the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate bone health and bone fracture incidence in kidney donors and non-kidney donors
Time frame: Baseline
Measured by participant self-report response to survey about bone fractures and bone health survey
Changes in bone health after kidney donation
Time frame: Day 1
As indicated by comparisons between kidney donors and non-donors of dual-energy X-ray absorptiometry (DXA) measurements of bone mineral density at the lumbar spine (L1-L4), total hip and distal 1/3 of the forearm (GE Lunar) by DXA. Will be expressed as a T-score offset from expected peak bone mass as contained in the DXA scanner manufacturers' database.
Incidence of differences in bone architecture and strength after kidney donation
Time frame: Day 1
By comparisons of kidney donors and non-donors in measures of volumetric density and bone microarchitecture at the distal radius and tibia by high-resolution peripheral quantitative computed tomography (HR-pQCT). Bone strength will be evaluated using Image Processing Language (IPL) software to generate microfinite element (μFE) models from HR-pQCT imaging.
Incidence of changes in blood counts and blood chemistry measures after kidney donation
Time frame: Day 1
Based on variations between donors and non-donors in measures of complete blood count, serum electrolytes, Ca, Pi, creatinine, blood urea nitrogen and albumin.
Assess the correlations of bone biomarker and serum hormone concentrations with bone mineral density.
Time frame: Day 1
Based on comparison of bone and serum biomarkers in kidney donors and non-donors: (NTX; CTX; TRAcP5b; OC; BAP; P1NP; sclerostin assay); 1,25(OH)2D; 25(OH)D2 and 25(OH)D3; parathyroid hormone (PTH); fibroblast growth factor-23 (FGF23).
Assess the correlations of renal function with bone mineral health.
Time frame: Day 1
Renal function will be assessed by Measured Glomerular Filtration Rate (GFR), using the iothalamate short renal clearance technique, and by 24 hour urine collection to record the measures of creatinine clearance, urinary excretion of calcium, phosphorus, albumin and protein.
2 secondary outcomes
Explore how vertebral Trabecular Bone Score (TBS) correlates with measures of bone health.
Time frame: Day 1
Evaluate Advanced Glycation Endproducts (AGEs) correlation to bone health parameters.
Time frame: Day 1
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 11 Oct 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Rajiv Kumar, M.D. principal investigator
Mayo Clinic
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 Renal Transplant Donor of Left Kidney and Renal Transplant Donor of Right Kidney, run by Mayo Clinic 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 11 inclusion and 12 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 11 Oct 2023. 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?
Evaluate bone health and bone fracture incidence in kidney donors and non-kidney donors (time frame: Baseline). The study lists 6 primary outcomes in all. 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 11 Oct 2023.