Shift to Everolimus (RAD) Kidney Sparing Study

This study has been terminated.
(A cluster of adverse events in everolimus arm was noted.)
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00420537
First received: January 9, 2007
Last updated: January 11, 2010
Last verified: May 2009

January 9, 2007
January 11, 2010
September 2006
January 2009   (final data collection date for primary outcome measure)
Calculated GFR [ Time Frame: One year after randomization ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00420537 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Shift to Everolimus (RAD) Kidney Sparing Study
Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients

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 cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Kidney Dysfunction
  • Heart Transplantation
  • Drug: cyclosporine
    cyclosporine trough levels between 100 and 150
  • Drug: cyclosporine
    cyclosporine trough levels between 40 and 90 ng/ml
  • Drug: Mycophenolate mofetil
    mycophenolate with low doses
  • Drug: Everolimus
  • Active Comparator: mycophenolate
    Mycophenolate mofetil with cyclosporine trough levels between 100 and 150
    Interventions:
    • Drug: cyclosporine
    • Drug: Mycophenolate mofetil
  • Active Comparator: Everolimus
    Everolimus with cyclosporine trough levels between 40 and 90 ng/ml
    Interventions:
    • Drug: cyclosporine
    • Drug: Everolimus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
March 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute rejection in the previous 6 months
  • Contraindications to statin therapy
  • Ongoing infection
  • Ongoing heart failure
  • Myocardial infarction or myocardial revascularization after transplant
  • Malignancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00420537
2006-003035-78
Not Provided
University of Bologna
University of Bologna
Not Provided
Study Chair: Angelo Branzi, MD Alma Mater Studiorum University of Bologna
University of Bologna
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP