Status:
COMPLETED
Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00170820
Start Date
February 1 2005
Last Update
February 27 2017
Active Locations (1)
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1
Novartis
Basel, Switzerland