- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01169701
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)
November 6, 2015 updated by: Novartis Pharmaceuticals
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.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid, Spain, 28041
- Novartis Investigative Site
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Madrid, Spain
- Novartis Investigative Site
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Madrid, Spain, 28040
- Novartis Investigative Site
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Andalucia
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Malaga, Andalucia, Spain, 29010
- Novartis Investigative Site
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Barcelona
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Hospitalet de Llobregat, Barcelona, Spain, 08907
- Novartis Investigative Site
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Catalunya
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Barcelona, Catalunya, Spain, 08035
- Novartis Investigative Site
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Barcelona, Catalunya, Spain, 08036
- Novartis Investigative Site
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Barcelona, Catalunya, Spain, 08025
- Novartis Investigative Site
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Cataluña
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Barcelona, Cataluña, Spain, 08003
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Tacrolimus
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
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Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study.
Other Names:
Myfortic® (MFS) was given as 720-1440 mg/day or 360-1440 mg/day.
Cell-Cept® (MMF) was given as 1000-2000 mg/day or 500-2000 mg/day.
Other Names:
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Experimental: Everolimus
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning.
On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus.
On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL.
Participants also continued with their MPA doses that were taken prior to study initiation.
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Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study.
Other Names:
Myfortic® (MFS) was given as 720-1440 mg/day or 360-1440 mg/day.
Cell-Cept® (MMF) was given as 1000-2000 mg/day or 500-2000 mg/day.
Other Names:
Everolimus was supplied in boxes with 60 tablets.
Available tablets: 1.0 mg, 0.5 mg and 0.25 mg.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Left Ventricular Mass Index (LVMI)
Time Frame: Baseline, Month 24
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Left ventricular hypertrophy grade was assessed by echocardiogram where the left ventricular mass index was calculated.
The presence of LVM was defined as > 49.2 g/m^2.7 in men and >46.7 g/m^2.7 in women.
A negative change from baseline indicates improvement.
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Baseline, Month 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure
Time Frame: Baseline, Month 6, month 12, month 24
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Blood pressure was measured using ambulatory blood pressure monitoring (ABPM).
A negative change from baseline indicates improvement.
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Baseline, Month 6, month 12, month 24
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Pulse Wave Velocity (PWV)
Time Frame: Month 6, month 24
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Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location.
The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.
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Month 6, month 24
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Percentage of Participants With Major Cardiovascular Events (MACE)
Time Frame: Month 24
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The percentage of participants who experienced MACE were reported.
MACE included acute myocardial infarction, insertion or replacement of implantable defibrillator, peripheral vascular disorders, congestive heart failure, coronary artery bypass, other events, percutaneous coronary intervention and stroke.
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Month 24
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Renal Function Measured by Serum Creatinine
Time Frame: Month 6, month 12, month 24
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Serum samples were collected to analyze serum creatinine.
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Month 6, month 12, month 24
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Renal Function as Measured by Creatinine Clearance
Time Frame: Month 6, month 12, month 24
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Creatinine clearance was calculated using the Cockroft-Gault formula.
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Month 6, month 12, month 24
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Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Month 6, month 12, month 24
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Estimated GFR was caluclated using the modification of diet in renal disease (MDRD) formula.
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Month 6, month 12, month 24
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Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP)
Time Frame: Baseline, month 6, month 24
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Blood samples were collected to analyze Troponin I and collagen type 1 C-telopeptide (ICTP).
A negative change from baseline indicates improvement.
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Baseline, month 6, month 24
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Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline, month 6, month 24
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Blood samples were collected to analyze HbA1c.
A negative change from baseline indicates improvement.
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Baseline, month 6, month 24
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Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO)
Time Frame: Baseline, month 6, month 24
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Blood samples were collected to analyze MPO.
A negative change from baseline indicates improvement.
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Baseline, month 6, month 24
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Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP)
Time Frame: Baseline, month 6, month 24
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Blood samples were collected to analyze NT-proBNP.
A negative change from baseline indicates improvement.
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Baseline, month 6, month 24
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Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP)
Time Frame: Baseline, month 6, month 24
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Blood samples were collected to analyze PCR.
A negative change from baseline indicates improvement.
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Baseline, month 6, month 24
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Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP)
Time Frame: Baseline, month 6, month 24
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Blood samples were collected to analyze CRP.
A negative change from baseline indicates improvement.
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Baseline, month 6, month 24
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Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up
Time Frame: Month 24
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The incidence of BPAR, graft loss, death and lost to follow-up events was calculated using relative frequency.
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Month 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
July 22, 2010
First Submitted That Met QC Criteria
July 23, 2010
First Posted (Estimate)
July 26, 2010
Study Record Updates
Last Update Posted (Estimate)
December 7, 2015
Last Update Submitted That Met QC Criteria
November 6, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Tacrolimus
- Mycophenolic Acid
- Everolimus
Other Study ID Numbers
- CRAD001AES07
- 2009-013780-19 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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