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Shift to Everolimus (RAD) Kidney Sparing Study

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ClinicalTrials.gov Identifier: NCT00420537
Recruitment Status : Terminated (A cluster of adverse events in everolimus arm was noted.)
First Posted : January 11, 2007
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Kidney Dysfunction Heart Transplantation Drug: cyclosporine Drug: Mycophenolate mofetil Drug: Everolimus Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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
Study Start Date : September 2006
Primary Completion Date : January 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Calculated GFR [ Time Frame: One year after randomization ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: January 11, 2007    Key Record Dates
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