Overview

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

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Tacrolimus
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