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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
History of Changes
  Purpose

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 Intervention Phase
Renal Transplantation
 Drug: Everolimus (RAD001)
Drug: Calcineurin Inhibitors (CNI)
Drug: Mycophenolate acid (MPA)/Azathioprine (AZA)
Drug: Steroids
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 394
Study Start Date: February 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170846

Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00170846     History of Changes
Other Study ID Numbers: CRAD001A2413
Study First Received: September 9, 2005
Results First Received: December 17, 2010
Last Updated: March 31, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Novartis:
Renal transplantation, everolimus, calcineurin inhibitors, GFR

Additional relevant MeSH terms:
Azathioprine
Mycophenolate mofetil
Everolimus
Sirolimus
Mycophenolic Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 17, 2013