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)

Novartis

Status and phase: Completed; Phase 4

Conditions: Renal Transplant

Treatments: Drug: Tacrolimus; Drug: Mycophenolic acid (MPA); Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01169701

2009-013780-19 (EudraCT Number)

CRAD001AES07

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Tacrolimus

Active Comparator group

Description:

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).

Treatment:

Drug: Mycophenolic acid (MPA)

Drug: Tacrolimus

Everolimus

Experimental group

Description:

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.

Treatment:

Drug: Everolimus

Drug: Mycophenolic acid (MPA)

Drug: Tacrolimus