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Shift to Everolimus (RAD) Kidney Sparing Study

This study has been terminated.
(A cluster of adverse events in everolimus arm was noted.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420537
First Posted: January 11, 2007
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Bologna
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420537


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

Publications:
Responsible Party: University of Bologna
ClinicalTrials.gov Identifier: NCT00420537     History of Changes
Other Study ID Numbers: 2006-003035-78
First Submitted: January 9, 2007
First Posted: January 11, 2007
Last Update Posted: January 12, 2010
Last Verified: May 2009

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

Additional relevant MeSH terms:
Everolimus
Sirolimus
Mycophenolic Acid
Cyclosporins
Cyclosporine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents