Novartis Everolimus Transition

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-05-31

Brief Summary

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Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.

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Detailed Description

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Conditions

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Graft Dysfunction Interstitial Fibrosis

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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Low intensity Tacrolimus

Low tacrolimus, everolimus, and steroids

Group Type ACTIVE_COMPARATOR

Everolimus

Intervention Type DRUG

Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus

Standard of Care

Tacrolimus, mycophenolate mofetil and steroids

Group Type OTHER

Standard of Care

Intervention Type OTHER

Tacrolimus, mycophenolate mofetil and steroids

Interventions

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Everolimus

Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus

Intervention Type DRUG

Standard of Care

Tacrolimus, mycophenolate mofetil and steroids

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. At least 18 years of age and able to give informed consent.
2. Received a first or repeat cadaveric (including ECD) or living donor renal transplant.
3. Patient has stable graft function, defined as no change of greater than 40% of baseline serum creatinine and no acute rejection during the past month.
4. Currently receiving tacrolimus, mycophenolate mofetil and prednisone as their immunosuppression regimen

Exclusion Criteria

1. Biopsy proven acute rejection episode that occurred within the past month.
2. Malignancy within the past 3 years, except for non-melanoma skin cancer.
3. Currently enrolled in an investigational drug trial.
4. Woman of child bearing potential not utilizing an effective form of birth control.
5. Patients with uncontrolled dyslipidemia, defined at serum fasting LDL \>200 mg/dL or serum fasting triglycerides \>500 mg/dL.
6. Patients with a spot urine protein to creatinine ratio of \> 800 mg of protein per gram of creatinine.
7. WBC \< 2,000 cells/mm3
8. Platelets \< 75,000 cells/mm3
9. Patients who have received an organ transplant other than a kidney.
10. Patients with a history of biopsy proven FSGS, MPGN, or PGN.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No