Shift to Everolimus (RAD) Kidney Sparing Study

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

Condition Intervention Phase
Kidney Dysfunction
Heart Transplantation
Drug: cyclosporine
Drug: Mycophenolate mofetil
Drug: Everolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients

Resource links provided by NLM:

Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Calculated GFR [ Time Frame: One year after randomization ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: September 2006
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mycophenolate
Mycophenolate mofetil with cyclosporine trough levels between 100 and 150
Drug: cyclosporine
cyclosporine trough levels between 100 and 150
Drug: Mycophenolate mofetil
mycophenolate with low doses
Active Comparator: Everolimus
Everolimus with cyclosporine trough levels between 40 and 90 ng/ml
Drug: cyclosporine
cyclosporine trough levels between 40 and 90 ng/ml
Drug: Everolimus


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT00420537

Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Sponsors and Collaborators
University of Bologna
Study Chair: Angelo Branzi, MD Alma Mater Studiorum University of Bologna
  More Information

Responsible Party: University of Bologna Identifier: NCT00420537     History of Changes
Other Study ID Numbers: 2006-003035-78 
Study First Received: January 9, 2007
Last Updated: January 11, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
Heart Transplantation
Glomerular Filtration Rate

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on April 27, 2016