Research with human participants

Overview of medical research in the Netherlands

Biomarkers of microvascular function, circulating cells and endothelial integrity in kidney transplant recipients on belatacept or CNI

Published:
Last updated:

To disclose the pathofysiologic basis of the favourable risk profile by measuring factors associated with cardiovascular disease.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Coronary artery disorders
Study type
Observational non invasive

ID

NL-OMON42067

Source

ToetsingOnline

Brief title

Cardiovascular biomarkers of KTR's on belatacept.

Condition

  • Coronary artery disorders
  • Diabetic complications
  • Arteriosclerosis, stenosis, vascular insufficiency and necrosis

Synonym

Cardiovascular disease

Research involving

Human

Sponsors and support

Primary sponsor :
Nierziekten
Source(s) of monetary or material Support :
Ministerie van OC&W,Er is een vergoeding door de sponsor va IM103-116 per geinculdeerde patient;waarvan de kosten voor dit onderzoek kunnen worden betaald

Intervention

Keyword :
Atherosclerosis, Belatacept, Cardiovascular risk, Kidney transplantation

Outcome measures

Primary outcome

Differences in circulating cells (endothelial cells and monocytes), angiogenic

and atheroscerotic factors, Micro-RNA's as well as in mean tortuosity index

(MTI).

Secondary outcome

none

Background summary

Belatacept has a favourable cardiovascular risk profile compared to
calcineurin-inhibitors, in kidney-transplant-recipients.

Study objective

To disclose the pathofysiologic basis of the favourable risk profile by
measuring factors associated with cardiovascular disease.

Study design

Measuring factors involved in cardiovascular risk in blood and by direct
visualisation of the buccal endothelium

Study burden and risks

None

Public
Selecteer

Albinusdreef 2
Leiden 2300RC
NL
Scientific
Selecteer

Albinusdreef 2
Leiden 2300RC
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Participance in IM-103-116.

Exclusion criteria

None

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Prevention

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
25
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leids Universitair Medisch Centrum (Leiden)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Leids Universitair Medisch Centrum (Leiden)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL49491.058.14