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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170846
First received: September 9, 2005
Last updated: March 31, 2011
Last verified: March 2011

September 9, 2005
March 31, 2011
February 2005
October 2009   (final data collection date for primary outcome measure)
Renal Function Assessed by Measured GFR (mGFR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00170846 on ClinicalTrials.gov Archive Site
Number of Participants With Safety Parameters [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
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ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients
Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplantation
  • Drug: Everolimus (RAD001)
  • Drug: Calcineurin Inhibitors (CNI)
  • Drug: Mycophenolate acid (MPA)/Azathioprine (AZA)
  • Drug: Steroids
  • Active Comparator: Group A: No RAD
    Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Drug: Everolimus (RAD001)
    • Drug: Calcineurin Inhibitors (CNI)
    • Drug: Mycophenolate acid (MPA)/Azathioprine (AZA)
    • Drug: Steroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
394
October 2009
October 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00170846
CRAD001A2413
Yes
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP