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Renal TransplantPhase 4EVITANCT01169701

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

A Phase 4 study testing Everolimus, Tacrolimus and Mycophenolic acid (MPA) in people with Renal Transplant, run by Novartis Pharmaceuticals at 9 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Transplant
What is being tested?
Everolimus, Tacrolimus and Mycophenolic acid (MPA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
9 sitesSpain
Study dates
Aug 2010to Mar 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08025

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Madrid, Madrid, 28041

  • Novartis Investigative Site

    Madrid, Madrid

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

Other trials in Spain

About this study

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.

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

Being tested
Everolimus, Tacrolimus, Mycophenolic acid (MPA)
Keywords
Renal transplant, everolimus, cardiovascular profile, CNI-free immunosuppression, left ventricular hypertrophy, biopsy proved acute rejection (BPAR)
Medical subject headings
Hypertrophy, Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    Also called Certican®

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

  • TacrolimusDrug

    Also called Prograf®, Advagraf®

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

  • Mycophenolic acid (MPA)Drug

    Also called Myfortic®, Cell-Cept®

    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.

Study groups in NCT01169701
Study groupRoleWhat they receive
TacrolimusActive comparatorParticipants 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).
Receives: Drug: Tacrolimus; Drug: Mycophenolic acid (MPA)
EverolimusExperimentalParticipants 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.
Receives: Drug: Everolimus; Drug: Tacrolimus; Drug: Mycophenolic acid (MPA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline, Month 24

Secondary outcomes (13)

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

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

    Measured: Baseline, Month 6, month 12, month 24

  2. Pulse Wave Velocity (PWV)

    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.

    Measured: Month 6, month 24

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

    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.

    Measured: Month 24

  4. Renal Function Measured by Serum Creatinine

    Serum samples were collected to analyze serum creatinine.

    Measured: Month 6, month 12, month 24

  5. Renal Function as Measured by Creatinine Clearance

    Creatinine clearance was calculated using the Cockroft-Gault formula.

    Measured: Month 6, month 12, month 24

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

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

    Measured: Month 6, month 12, month 24

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

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

    Measured: Baseline, month 6, month 24

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

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

    Measured: Baseline, month 6, month 24

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

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

    Measured: Baseline, month 6, month 24

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

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

    Measured: Baseline, month 6, month 24

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

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

    Measured: Baseline, month 6, month 24

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

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

    Measured: Baseline, month 6, month 24

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

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

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01169701
Sponsor's protocol ID
CRAD001AES07
Other IDs
2009-013780-19, 2009
Acronym
EVITA
Status last verified
Nov 2015
First submitted
22 Jul 2010
Last updated
7 Dec 2015

Publications

  • Cruzado JM, Pascual J, Sanchez-Fructuoso A, Seron D, Diaz JM, Rengel M, Oppenheimer F, Hernandez D, Paravisini A, Saval N, Morales JM; Evita Study Group. Controlled randomized study comparing the cardiovascular profile of everolimus with tacrolimus in renal transplantation. Transpl Int. 2016 Dec;29(12):1317-1328. doi: 10.1111/tri.12862. Epub 2016 Oct 17.

    PubMed 27648523

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Everolimus, Tacrolimus and Mycophenolic acid (MPA) in people with Renal Transplant, run by Novartis Pharmaceuticals at 9 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Left Ventricular Mass Index (LVMI) (time frame: Baseline, Month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01169701, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.

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EVITA Clinical Trial NCT01169701 | AzTrials