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ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00170846
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : May 2, 2011
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients with renal impairment by reducing the progression of chronic allograft nephropathy. The development of atherosclerosis in the native arteries of the patients will also be explored.

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients
Study Start Date : February 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patient at least 18 years of age.
  • Patient who has undergone a primary or secondary renal transplant 12-96 months ago from a living related or unrelated donor or a cadaveric donor.
  • Patient receiving cyclosporine microemulsion with a C2-h level ≥ 400 ng/mL or tacrolimus with a C0-h level ≥ 4 ng/mL with or without mycophenolic acid or azathioprine plus or minus steroids.
  • The immunosuppressive regimen must remain unchanged within the last 3 months.
  • Patient with renal impairment defined as GFR between 30 and 70 mL/min/1.73 m^2 by Cockcroft-Gault formula.

Exclusion Criteria:

  • Patient who is recipient of multiple organ transplants.
  • Patient with protein/creatinine ratio ≥ 150 (mg/mmol).
  • Patient with a treated acute rejection episode within the last 3 months.
  • Patient with any past or present BK-polyomavirus nephropathy.
  • Patient with de novo or recurrent glomerular nephritis.

Other protocol defined inclusion/exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Novartis
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00170846    
Other Study ID Numbers: CRAD001A2413
First Posted: September 15, 2005    Key Record Dates
Results First Posted: May 2, 2011
Last Update Posted: January 27, 2015
Last Verified: March 2011
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Renal transplantation, everolimus, calcineurin inhibitors, GFR
Additional relevant MeSH terms:
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Everolimus
Azathioprine
Calcineurin Inhibitors
MTOR Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antirheumatic Agents