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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: No RAD

Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids

Group Type ACTIVE_COMPARATOR

Calcineurin Inhibitors (CNI)

Intervention Type DRUG

Mycophenolate acid (MPA)/Azathioprine (AZA)

Intervention Type DRUG

Steroids

Intervention Type DRUG

Group B : CNI Withdrawal

Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus(RAD001) 4 mg initial daily dose.

Group Type EXPERIMENTAL

Everolimus (RAD001)

Intervention Type DRUG

Mycophenolate acid (MPA)/Azathioprine (AZA)

Intervention Type DRUG

Steroids

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Everolimus (RAD001)

Intervention Type DRUG

Calcineurin Inhibitors (CNI)

Intervention Type DRUG

Mycophenolate acid (MPA)/Azathioprine (AZA)

Intervention Type DRUG

Steroids

Intervention Type DRUG

Interventions

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Everolimus (RAD001)

Intervention Type DRUG

Calcineurin Inhibitors (CNI)

Intervention Type DRUG

Mycophenolate acid (MPA)/Azathioprine (AZA)

Intervention Type DRUG

Steroids

Intervention Type DRUG

Eligibility 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No