A 24 months, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin inhibitor to everolimus conversio

• Conditions: De Novo renal transplantation

• Registration Number: EUCTR2009-015918-22-LV
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-07
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 676

Inclusion Criteria

- Male or female renal allograft recipients at least 18 years old.
- Patients who have given written informed consent to participate in the study. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
- Patient who has received a primary or secondary kidney transplant from a cadaveric or living unrelated-/related donor.
- Recipient of a kidney allograft with a cold ischemia time (CIT) < 24 hours.
- Female patients must have a negative pregnancy test prior to study enrollment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Recipient of multiple organ transplants.
- Recipient of ABO incompatible allograft or a positive cross-match.
- Patient with most recent Panel Reactive Antibodies (PRA) level = 30 % or a positive luminex test for any permitted antigen of the recipient
- Patient who is human immunodeficiency virus (HIV) positive.
- Patient who received an allograft from a Hepatitis B surface Antigen (HBsAg) or a Hepatitis C Virus (HCV) positive donor.
- HBsAg and/or a HCV positive patient with evidence of elevated LFTs (ALT/AST levels = 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable.
- Patient with severe restrictive or obstructive pulmonary disorders.
- Patient with severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment that would prevent patient from potential exposure to everolimus, or with hypersensitivity to drugs similar to everolimus (e.g. macrolides).
- Patient with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
- Patient with white blood cell (WBC) count < 2,000 /mm3 or with platelet count
< 50,000 /mm3.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate superior renal allograft function in de novo renal transplant recipients after early conversion from CNI to everolimus, assessed by Glomerular Filtration Rate (eGFR) estimated by the Modification of Diet in Renal Disease formula 4 (MDRD4) at Month 12 versus the active control;Secondary Objective: - To demonstrate non-inferior efficacy (defined by a composite efficacy endpoint of treated Biopsy Proven Acute Rejection (BPAR) = IB, graft loss or death) at Month 12.<br>- To demonstrate improvement of Left Ventricular Hypertrophy (LVH) in comparable patients (assessed by LV mass index, LVMi) by echocardiogram at Month 12.<br>;Primary end point(s): To demonstrate superior renal allograft function in de novo renal transplant recipients after early CNI to everolimus conversion assessed by Glomerular Filtration Rate (eGFR) estimated by the Modification of Diet in Renal Disease formula 4 (MDRD4) at Month 12 versus the active control