24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients (EVITA)

This study is currently recruiting participants.
Verified March 2014 by Novartis
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: July 22, 2010
Last updated: March 4, 2014
Last verified: March 2014

The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant patients

Condition Intervention Phase
Renal Transplant
Drug: tacrolimus
Drug: everolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-label, Randomized, 24 Months Follow-up, Two Arm Study to Compare the Efficacy of Everolimus in Improving the Cardiovascular Profile in a Regimen With Mycophenolic Acid vs. a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients.

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • reduction of left ventricular hypertrophy (LVH) at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to assess the pulse wave velocity (PWV)in the two treatment arms [ Time Frame: 6 months and 24 months ] [ Designated as safety issue: No ]
  • to compare the carotid echography and MACE (major cardiovascular events) between the two arms. [ Time Frame: 3rd, 7th and 12th months ] [ Designated as safety issue: Yes ]
  • comparison of renal function (eGFR calculated by the aMDRD formula, creatinine clearance using the Cockcroft-Gault formula, serum creatinine) between the two arms. [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • To compare efficacy between the two groups of treatment by means of BPAR, graft loss, death and lost to follow up [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2010
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus Drug: everolimus
Active Comparator: Tacrolimus Drug: tacrolimus


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Received kidney transplant > 6 months and < 3 years prior to study enrollment
  • Receiving immunosuppressive regimen that includes tacrolimus and mycophenolic acid
  • Between 18 and 70 years of age
  • Willing to provide written informed consent

Exclusion Criteria:

  • Patients with an actual serum creatinine ≥ 2 mg/dl and/or eGFR≤ 40 ml/min and/or proteinuria≥ 500mg/day
  • Patients who suffered from severe humoral and/or cellular rejection (≥ BANFF IIb, recurrent acute rejection or steroid resistant acute rejection in the previous years
  • Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable.
  • Diabetic patients
  • Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception
  • Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
  • Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study
  • Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169701

Contact: Novartis Pharmaceuticals 61-324-1111 ext 0041

Novartis Investigative Site Recruiting
Barcelona, Spain
Contact: Novartis Spain    93 306 42 00 ext +34      
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01169701     History of Changes
Other Study ID Numbers: CRAD001AES07, 2009-013780-19
Study First Received: July 22, 2010
Last Updated: March 4, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
Renal transplant, everolimus, cardiovascular profile, CNI-free immunosuppression, left ventricular hypertrophy, biopsy proved acute rejection (BPAR)

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

ClinicalTrials.gov processed this record on April 15, 2014