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Completed

NCT Number: 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

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

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Key information

Conditions

Renal Transplant Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Málaga, Andalusia, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

Everolimus was supplied in boxes with 60 tablets. Available tablets: 1.0 mg, 0.5 mg and 0.25 mg.

Other names: Certican®

Tacrolimus

Drug

Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study.

Other names: Prograf®, Advagraf®

Mycophenolic Acid (MPA)

Drug

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: Myfortic®, Cell-Cept®

Primary outcomes

  1. Change From Baseline in Left Ventricular Mass Index (LVMI)

    Time frame: Baseline, Month 24

    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.

Secondary outcomes

  1. Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure

    Time frame: Baseline, Month 6, month 12, month 24

    Blood pressure was measured using ambulatory blood pressure monitoring (ABPM). A negative change from baseline indicates improvement.

  2. Pulse Wave Velocity (PWV)

    Time frame: Month 6, month 24

    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.

  3. Percentage of Participants With Major Cardiovascular Events (MACE)

    Time frame: Month 24

    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.

  4. Renal Function Measured by Serum Creatinine

    Time frame: Month 6, month 12, month 24

    Serum samples were collected to analyze serum creatinine.

  5. Renal Function as Measured by Creatinine Clearance

    Time frame: Month 6, month 12, month 24

    Creatinine clearance was calculated using the Cockroft-Gault formula.

  6. Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Month 6, month 12, month 24

    Estimated GFR was caluclated using the modification of diet in renal disease (MDRD) formula.

  7. Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP)

    Time frame: Baseline, month 6, month 24

    Blood samples were collected to analyze Troponin I and collagen type 1 C-telopeptide (ICTP). A negative change from baseline indicates improvement.

  8. Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline, month 6, month 24

    Blood samples were collected to analyze HbA1c. A negative change from baseline indicates improvement.

  9. Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO)

    Time frame: Baseline, month 6, month 24

    Blood samples were collected to analyze MPO. A negative change from baseline indicates improvement.

  10. Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP)

    Time frame: Baseline, month 6, month 24

    Blood samples were collected to analyze NT-proBNP. A negative change from baseline indicates improvement.

  11. Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP)

    Time frame: Baseline, month 6, month 24

    Blood samples were collected to analyze PCR. A negative change from baseline indicates improvement.

  12. Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP)

    Time frame: Baseline, month 6, month 24

    Blood samples were collected to analyze CRP. A negative change from baseline indicates improvement.

  13. Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up

    Time frame: Month 24

    The incidence of BPAR, graft loss, death and lost to follow-up events was calculated using relative frequency.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Acronym: EVITA

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2010
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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