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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplant
Keywords: Renal transplant, everolimus, cardiovascular profile, CNI-free immunosuppression, left ventricular hypertrophy, biopsy proved acute rejection (BPAR)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-07-26
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Left Ventricular Mass Index (LVMI)
timeFrame: Baseline, Month 24
Secondary outcomes:
measure: Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure
timeFrame: Baseline, Month 6, month 12, month 24
measure: Pulse Wave Velocity (PWV)
timeFrame: Month 6, month 24
measure: Percentage of Participants With Major Cardiovascular Events (MACE)
timeFrame: Month 24
measure: Renal Function Measured by Serum Creatinine
timeFrame: Month 6, month 12, month 24
measure: Renal Function as Measured by Creatinine Clearance
timeFrame: Month 6, month 12, month 24
measure: Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Month 6, month 12, month 24
measure: Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP)
timeFrame: Baseline, month 6, month 24
measure: Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, month 6, month 24
measure: Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO)
timeFrame: Baseline, month 6, month 24
measure: Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP)
timeFrame: Baseline, month 6, month 24
measure: Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP)
timeFrame: Baseline, month 6, month 24
measure: Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP)
timeFrame: Baseline, month 6, month 24
measure: Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up
timeFrame: Month 24
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.