Fractures and Bone Disease in Living Kidney Donors

NCT ID: NCT04810884

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4415 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2023-08-04

Brief 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. 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.

Conditions

Renal Transplant Donor of Left Kidney; Renal Transplant Donor of Right Kidney

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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.
• 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

Exclusion Criteria

Aim 1: Survey (Donors):

• Deceased
• Not willing to return the survey.

Aim 1: Survey (Controls):

• Deceased
• Not willing to return the survey
• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Rajiv Kumar, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajiv Kumar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

R01DK125252

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-004432

Identifier Type: -

Identifier Source: org_study_id