Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation

Renal Transplantation Clinical Trial

— NOCTX-2  

Official title:

Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01276834
• Other study ID #: NOCTX-2
• Secondary ID: 2009-011605-16
• Status: Terminated
• Phase: Phase 4
• First received: January 12, 2011
• Last updated: August 4, 2017
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2017
• Source: Dianet Dialysis Centers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Renal Transplantation

Intervention

Drug:
• everolimus
comparison of everolimus-based and CNI-based immunosuppression

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Dianet Dialysis Centers	UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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