NCT01276834

Brief Summary

To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

January 12, 2011

Last Update Submit

August 4, 2017

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (1)

  • change in coronary artery calcification score

    Comparison in a randomised way the effect of a calcineurin-based immunosuppressive regimen with an mTOR-based regimen on progression of coronary calcification on renal transplant patients. The results of this study will provide more insight in protection against cardiovascular disease in renal transplant patients.

    3 years

Study Arms (2)

everolimus-based immunosuppression

EXPERIMENTAL

immunosuppression with everolimus, prednisone and mycophenolate

Drug: everolimus

standard immunosuppression

ACTIVE COMPARATOR

immunosuppression with tacrolimus, prednisone and mycophenolate

Drug: everolimus

Interventions

everolimusDRUG

comparison of everolimus-based and CNI-based immunosuppression

everolimus-based immunosuppressionstandard immunosuppression

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-75 yr
  • Willingness to provide written informed consent
  • Ability to understand the study procedures

You may not qualify if:

  • Life expectancy \< 3 months
  • Claustrophobia
  • Allergy to iodinated contrast
  • Treatment incompliance
  • Pregnancy
  • Highly HLA-sensitized patients
  • Severe dyslipidemia or proteinuria
  • Severe leucopenia or thrombocytopenia
  • GFR \< 30 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Franka E van Reekum, MD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

September 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 7, 2017

Record last verified: 2017-08

Locations

NL(1)