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
  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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Study First Received: January 9, 2007
Last Updated: January 11, 2010
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014