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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00170846 |
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Date of registration:
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09/09/2005 |
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Primary sponsor: |
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Public title:
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ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients
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Scientific title:
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Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients |
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Date of first enrolment:
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February 2005 |
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Target sample size:
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394 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00170846 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Novartis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Transplantation
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Intervention(s)
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Drug: Calcineurin Inhibitors (CNI)
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Drug: Everolimus (RAD001)
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Drug: Mycophenolate acid (MPA)/Azathioprine (AZA)
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Drug: Steroids
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Primary Outcome(s)
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Renal Function Assessed by Measured GFR (mGFR)
[Time Frame: 24 months]
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Secondary Outcome(s)
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Number of Participants With Safety Parameters
[Time Frame: 24 months]
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Secondary ID(s)
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CRAD001A2413
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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