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

This study has been terminated.

(insufficient patients enrolled)

Sponsor:

Collaborator:

UMC Utrecht

Information provided by (Responsible Party):

dr. M.P. Kooistra, Dianet Dialysis Centers

ClinicalTrials.gov Identifier:

NCT01276834

First received: January 12, 2011

Last updated: August 11, 2015

Last verified: August 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
Renal Transplantation	Drug: everolimus	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Dianet Dialysis Centers:

Primary Outcome Measures:

change in coronary artery calcification score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.


Enrollment:	13
Study Start Date:	September 2010
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: everolimus-based immunosuppression immunosuppression with everolimus, prednisone and mycophenolate	Drug: everolimus comparison of everolimus-based and CNI-based immunosuppression
Active Comparator: standard immunosuppression immunosuppression with tacrolimus, prednisone and mycophenolate	Drug: everolimus comparison of everolimus-based and CNI-based immunosuppression

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276834

Locations


Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX

Sponsors and Collaborators

Dianet Dialysis Centers

UMC Utrecht

Investigators


Principal Investigator:	Franka E van Reekum, MD	UMC Utrecht

More Information


Responsible Party:	dr. M.P. Kooistra, MD, PhD, Dianet Dialysis Centers
ClinicalTrials.gov Identifier:	NCT01276834 History of Changes
Other Study ID Numbers:	NOCTX-2 2009-011605-16
Study First Received:	January 12, 2011
Last Updated:	August 11, 2015
Health Authority:	The Netherlands:METC University Medical Center Utrecht

Additional relevant MeSH terms:


Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Everolimus Sirolimus Antineoplastic Agents	Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents

ClinicalTrials.gov processed this record on September 29, 2016

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