Renal TransplantASCITNCT00547040
Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
An observational study of Renal Transplant and Atherosclerosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to determine the: Natural history of calcification posttransplantation Natural history of BMC following renal transplantation Reverse correlation between calcification score and aortic calcifications following renal transplantation Correlation of IMT, BMC, PWV and biochemical variables… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Transplant, Atherosclerosis, Arterial Stiffness
- How many people
- 304 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2006to Oct 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: incident renal transplant recipients
Who may be able to join
- Incident renal transplant patients or combined renal/pancreas transplant patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the:
- Natural history of calcification posttransplantation
- Natural history of BMC following renal transplantation
- Reverse correlation between calcification score and aortic calcifications following renal transplantation
- Correlation of IMT, BMC, PWV and biochemical variables
- Correlation of IMT, BMC, PWV, biochemical variables and outcome
- Predictors of CV disease after transplantation
- Predictors of IMT progression, BMC loss and PWV progression after renal transplantation
- Conditions
- Renal Transplant, Atherosclerosis, Arterial Stiffness
- Being tested
- no intervention
- Keywords
- calcification, bone lesions
- Medical subject headings
- Atherosclerosis, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| A | incident renal transplant patients Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular outcome
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startOct 2006
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Claes, Universitaire Ziekenhuizen KU Leuven
- Investigators
- kathleen Claes, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547040
- Sponsor's protocol ID
- ML3775
- Acronym
- ASCIT
- Status last verified
- Oct 2011
- First submitted
- 18 Oct 2007
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38030558Evenepoel P, Claes K, Viaene L, Bammens B, Meijers B, Naesens M, Sprangers B, Kuypers D. Decreased Circulating Sclerostin Levels in Renal Transplant Recipients With Persistent Hyperparathyroidism. Transplantation. 2016 Oct;100(10):2188-93. doi: 10.1097/TP.0000000000001311.
PubMed 27379556Claes KJ, Heye S, Bammens B, Kuypers DR, Meijers B, Naesens M, Vanrenterghem Y, Evenepoel P. Aortic calcifications and arterial stiffness as predictors of cardiovascular events in incident renal transplant recipients. Transpl Int. 2013 Oct;26(10):973-81. doi: 10.1111/tri.12151. Epub 2013 Jul 19.
PubMed 23870026
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00547040
- Acronym / sponsor ID
- ASCIT / ML3775
- Conditions
- Renal Transplant, Atherosclerosis, Arterial Stiffness
- Keywords
- calcification, bone lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2006 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Oct 2007 (estimated)
- 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.
The purpose of this study is to determine the:
- Natural history of calcification posttransplantation
- Natural history of BMC following renal transplantation
- Reverse correlation between calcification score and aortic calcifications following renal transplantation
- Correlation of IMT, BMC, PWV and biochemical variables
- Correlation of IMT, BMC, PWV, biochemical variables and outcome
- Predictors of CV disease after transplantation
- Predictors of IMT progression, BMC loss and PWV progression after renal transplantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: no interventionincident renal transplant patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- incident renal transplant recipients
Key inclusion criteria (1 listed)
- Incident renal transplant patients or combined renal/pancreas transplant patients
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| no interventionno intervention | Other | A |
Primary outcome
cardiovascular outcome
Time frame: 5 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 16 Oct 2018.
- Derived from this study: PubMed 38030558Jorgensen 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.
- Derived from this study: PubMed 27379556Evenepoel P, Claes K, Viaene L, Bammens B, Meijers B, Naesens M, Sprangers B, Kuypers D. Decreased Circulating Sclerostin Levels in Renal Transplant Recipients With Persistent Hyperparathyroidism. Transplantation. 2016 Oct;100(10):2188-93. doi: 10.1097/TP.0000000000001311.
- Derived from this study: PubMed 23870026Claes KJ, Heye S, Bammens B, Kuypers DR, Meijers B, Naesens M, Vanrenterghem Y, Evenepoel P. Aortic calcifications and arterial stiffness as predictors of cardiovascular events in incident renal transplant recipients. Transpl Int. 2013 Oct;26(10):973-81. doi: 10.1111/tri.12151. Epub 2013 Jul 19.
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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.
kathleen Claes, MD principal investigator
UZ Leuven
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 and Atherosclerosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 0 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 16 Oct 2018. 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 Belgium. 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?
cardiovascular outcome (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00547040, which also lists 3 linked publications.
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 16 Oct 2018.