NCT00547040

Brief 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
  • 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2011

Enrollment Period

7 years

First QC Date

October 18, 2007

Last Update Submit

October 13, 2018

Conditions

Keywords

calcificationbone lesions

Outcome Measures

Primary Outcomes (1)

  • cardiovascular outcome

    5 years

Study Arms (1)

A

incident renal transplant patients

Other: no intervention

Interventions

no intervention

A

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

incident renal transplant recipients

You may qualify if:

  • Incident renal transplant patients or combined renal/pancreas transplant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (3)

  • 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.

  • Evenepoel 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.

  • Claes 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma, urine

MeSH Terms

Conditions

AtherosclerosisCalcinosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • kathleen Claes, MD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 19, 2007

Study Start

October 1, 2006

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 16, 2018

Record last verified: 2011-10

Locations