ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00170846|
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : May 2, 2011
Last Update Posted : January 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplantation||Drug: Everolimus (RAD001) Drug: Calcineurin Inhibitors (CNI) Drug: Mycophenolate acid (MPA)/Azathioprine (AZA) Drug: Steroids||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||394 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients|
|Study Start Date :||February 2005|
|Primary Completion Date :||October 2009|
|Study Completion Date :||October 2009|
Active Comparator: Group A: No RAD
Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
|Drug: Calcineurin Inhibitors (CNI) Drug: Mycophenolate acid (MPA)/Azathioprine (AZA) Drug: Steroids|
Experimental: Group B : CNI Withdrawal
Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus(RAD001) 4 mg initial daily dose.
|Drug: Everolimus (RAD001) Drug: Mycophenolate acid (MPA)/Azathioprine (AZA) Drug: Steroids|
Experimental: Group C: CNI Reduction
Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
|Drug: Everolimus (RAD001) Drug: Calcineurin Inhibitors (CNI) Drug: Mycophenolate acid (MPA)/Azathioprine (AZA) Drug: Steroids|
- Renal Function Assessed by Measured GFR (mGFR) [ Time Frame: 24 months ]The acceptable methods for GFR measurement were Chromium 51-Ethylenediaminetetra acetic acid (Cr-EDTA), Technetium 99-Diethylenetriaminepentacetic acid (Tc-DTPA), Iohexol clearance Inuline clearance and Iothalamate clearance. The method should have been consistent for a given patient at every time point.
- Number of Participants With Safety Parameters [ Time Frame: 24 months ]The selected safety parameters (such as hypertension, hyperlipidemia, diabetes mellitus, anemia, malignancies ) were derived based on adverse events preferred terms defined in the analysis plan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170846