ASCIT: Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT00547040
• Collaborator: (none)
• Enrollment: 304
• Location: 1
• Actual Duration (Months): 84
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant; Atherosclerosis; Arterial Stiffness	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 304 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
• Actual Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
A incident renal transplant patients	Other: no intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. cardiovascular outcome [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Gasthuisberg	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

• Principal Investigator: kathleen Claes, MD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathleen Claes, md, Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT00547040
• Other Study ID Numbers: ML3775
• First Posted: Oct 19, 2007
• Last Update Posted: Oct 16, 2018
• Last Verified: Oct 1, 2011

• Keywords provided by Kathleen Claes, md, Universitaire Ziekenhuizen Leuven: calcification; bone lesions
• Additional relevant MeSH terms: Atherosclerosis; Calcinosis

Study Results

No Results Posted as of Oct 16, 2018