Status:

TERMINATED

Shift to Everolimus (RAD) Kidney Sparing Study

Lead Sponsor:

University of Bologna

Conditions:

Kidney Dysfunction

Heart Transplantation

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclospori...

Eligibility Criteria

Inclusion

  • Heart Transplant with 1 to 4 years of follow-up
  • GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)

Exclusion

  • Acute rejection in the previous 6 months
  • Contraindications to statin therapy
  • Ongoing infection
  • Ongoing heart failure
  • Myocardial infarction or myocardial revascularization after transplant
  • Malignancy

Key Trial Info

Start Date :

September 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT00420537

Start Date

September 1 2006

End Date

March 1 2009

Last Update

January 12 2010

Active Locations (1)

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Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138