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Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation (NOCTX-2)

Primary Purpose

Renal Transplantation

Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
everolimus
Sponsored by
Dianet Dialysis Centers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Medical Center Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

everolimus-based immunosuppression

standard immunosuppression

Arm Description

immunosuppression with everolimus, prednisone and mycophenolate

immunosuppression with tacrolimus, prednisone and mycophenolate

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2011
Last Updated
August 4, 2017
Sponsor
Dianet Dialysis Centers
Collaborators
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT01276834
Brief Title
Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation
Acronym
NOCTX-2
Official Title
Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
insufficient patients enrolled
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dianet Dialysis Centers
Collaborators
UMC Utrecht

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
everolimus-based immunosuppression
Arm Type
Experimental
Arm Description
immunosuppression with everolimus, prednisone and mycophenolate
Arm Title
standard immunosuppression
Arm Type
Active Comparator
Arm Description
immunosuppression with tacrolimus, prednisone and mycophenolate
Intervention Type
Drug
Intervention Name(s)
everolimus
Intervention Description
comparison of everolimus-based and CNI-based immunosuppression
Primary Outcome Measure Information:
Title
change in coronary artery calcification score
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-75 yr Willingness to provide written informed consent Ability to understand the study procedures Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franka E van Reekum, MD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation

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