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

D

Dianet Dialysis Centers

Status and phase

Terminated
Phase 4

Conditions

Renal Transplantation

Treatments

Drug: everolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT01276834
2009-011605-16 (EudraCT Number)
NOCTX-2

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

13 participants in 2 patient groups

everolimus-based immunosuppression
Experimental group
Description:
immunosuppression with everolimus, prednisone and mycophenolate
Treatment:
Drug: everolimus
standard immunosuppression
Active Comparator group
Description:
immunosuppression with tacrolimus, prednisone and mycophenolate
Treatment:
Drug: everolimus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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