MedPath

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

Phase 4
Completed
Conditions
Renal Transplantation
Registration Number
NCT00170820
Lead Sponsor
Novartis Pharmaceuticals
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Renal function at M6 (glomerular filtration and tubular function).
Secondary Outcome Measures
NameTimeMethod
Mucous and cutaneous disorders
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
Renal function (other tubular function parameters)
Incidence of biopsy-proven acute rejections and CMV infections
Monitoring of everolimus trough levels.
Adverse events and serious adverse events, premature study treatment discontinuations.

Trial Locations

Locations (1)

Novartis

🇨🇭

Basel, Switzerland

Novartis
🇨🇭Basel, Switzerland

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.