Phase 4
Completed N=71
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
Renal Transplant
Source: ClinicalTrials.gov NCT01169701 ↗
Enrolled (actual)
71
Serious AEs
18.3%
Results posted
Apr 2015
Primary outcomePrimary: Change From Baseline in Left Ventricular Mass Index (LVMI) — -6.071; -4.008 g/m^2.7
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Left Ventricular Mass Index (LVMI) |
-6.071; -4.008 | — |
| SECONDARY Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure |
-0.6; 3.2; 2.1; 2.7; 2.2; 2.0 | — |
| SECONDARY Pulse Wave Velocity (PWV) |
7.01; 7.40; 7.58; 7.06 | — |
| SECONDARY Percentage of Participants With Major Cardiovascular Events (MACE) |
0.00; 0.00 | — |
| SECONDARY Renal Function Measured by Serum Creatinine |
1.232; 1.234; 1.231; 1.256; 1.217; 1.260 | — |
| SECONDARY Renal Function as Measured by Creatinine Clearance |
64.841; 76.618; 65.037; 73.363; 66.933; 72.910 | — |
| SECONDARY Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR) |
55.648; 63.781; 57.757; 61.225; 57.727; 60.779 | — |
| SECONDARY Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP) |
0.000; -0.006; 0.003; -0.007; 0.049; -0.195 | — |
| SECONDARY Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c) |
0.015; 0.159; 0.045; 0.185 | — |
| SECONDARY Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO) |
0.433; -0.093; -0.329; -0.642 | — |
| SECONDARY Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP) |
21.604; -79.10; -80.20; -193.3 | — |
| SECONDARY Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP) |
-13.82; -33.36; -13.65; -28.17 | — |
| SECONDARY Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP) |
0.512; 0.326; 0.100; -0.040 | — |
| SECONDARY Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Received kidney transplant > 6 months and 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
Data sourced from ClinicalTrials.gov (NCT01169701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.