Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: September 9, 2005
Last updated: November 1, 2011
Last verified: November 2011
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Single Arm, Prospective, Open-label, Pilot Study to Assess Effects of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Renal function at M6 (glomerular filtration and tubular function).
Secondary Outcome Measures:
- 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.
|Study Start Date:||February 2005|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
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