Novartis Everolimus Transition



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:8/10/2018
Start Date:February 2014
End Date:May 2017

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Safety and Efficacy of Everolimus Transition in Minimizing Progressive Graft Dysfunction and Interstitial Fibrosis in Adult Kidney Transplant Recipients

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.


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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Titte Srinivas, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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mi
from
Charleston, SC
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