Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

Novartis Pharmaceuticals20 enrolled

Overview

The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

EverolimusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * First or second renal transplantation (1 to 10 years post-transplant) * Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin Exclusion Criteria * Treatment with a CNI or azathioprine * Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening * Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

Renal function at M6 (glomerular filtration and tubular function).

Secondary Outcomes

Renal function (other tubular function parameters)

Incidence of biopsy-proven acute rejections and CMV infections

Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH

Mucous and cutaneous disorders

Adverse events and serious adverse events, premature study treatment discontinuations.

Monitoring of everolimus trough levels.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.