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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 January 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01169701
First received: July 22, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus Drug: everolimus
Active Comparator: Tacrolimus Drug: tacrolimus

  Eligibility

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

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

Contacts
Contact: Novartis Pharmaceuticals 61-324-1111 ext 0041

Locations
Spain
Novartis Investigative Site Recruiting
Barcelona, Spain
Contact: Novartis Spain     93 306 42 00 ext +34        
Sponsors and Collaborators
Novartis
  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: January 15, 2013
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
Sirolimus
Mycophenolate mofetil
Everolimus
Tacrolimus
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 May 23, 2013