Evolution of Bone Histomorphometry and Vascular Calcification Before and After Renal Transplantation
A Prospective Observational Study to Investigate the Natural History of Bone Histomorphometry and Vascular Calcification in Dialysis-dependent Patients Before and After Renal Transplantation.
1 other identifier
observational
250
1 country
1
Brief Summary
A study of the natural history of bone and mineral disease (BMD) in patients with end-stage renal disease before and after kidney transplantation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJuly 3, 2024
July 1, 2024
15.3 years
June 12, 2013
July 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
bone turnover, as assessed by bone biopsy
to investigate the role of indoxyl sulfate and p-cresyl sulfate in the pathogenesis and progression of ABD and arterial calcification in CKD stage5
at the start of the study
Evolution of bone turnover, as assessed by bone biopsy
to evoluation the evolution of bone turnover after succesfull renal transplantation
after 1 year
aortic calcification, as assessed by lumbar X-ray
the assess the evolution of (the degree of) aortic calcification one year after succesfull renal transplantation
1 year
Eligibility Criteria
end stage renal disease patients able to consent
You may qualify if:
- eligible for renal transplantation and \>18 years
You may not qualify if:
- use of biphosphonates within the 6 months before the study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven Gasthuisberg
Leuven, Vlaams-Brabant, 3000, Belgium
Related Publications (2)
Jorgensen HS, Claes K, Smout D, Naesens M, Kuypers D, D'Haese P, Cavalier E, Evenepoel P. Associations of Changes in Bone Turnover Markers with Change in Bone Mineral Density in Kidney Transplant Patients. Clin J Am Soc Nephrol. 2024 Apr 1;19(4):483-493. doi: 10.2215/CJN.0000000000000368. Epub 2023 Nov 29.
PMID: 38030558DERIVEDJorgensen HS, Behets G, Bammens B, Claes K, Meijers B, Naesens M, Sprangers B, Kuypers DRJ, Cavalier E, D'Haese P, Evenepoel P. Natural History of Bone Disease following Kidney Transplantation. J Am Soc Nephrol. 2022 Mar;33(3):638-652. doi: 10.1681/ASN.2021081081. Epub 2022 Jan 19.
PMID: 35046132DERIVED
Biospecimen
Bone biopsy Serum samples A. epigastrica inferior
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pieter Evenepoel, MD,PhD
UZ Leuven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 26, 2013
Study Start
August 1, 2010
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
July 3, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share