Novartis Everolimus Transition
Completed · Phase 4
Conditions studied: Graft Dysfunction, Interstitial Fibrosis
In brief
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.
Key facts
- Study ID
- NCT02096107
- Run by
- Medical University of South Carolina
- People needed
- 60
- Starts
- 2014-02-01
- Expected to finish
- 2017-05-01
- Last updated by the study team
- 2018-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 18 years of age and able to give informed consent.
- Received a first or repeat cadaveric (including ECD) or living donor renal transplant.
- 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.
- Currently receiving tacrolimus, mycophenolate mofetil and prednisone as their immunosuppression regimen
You may not qualify if…
- Biopsy proven acute rejection episode that occurred within the past month.
- Malignancy within the past 3 years, except for non-melanoma skin cancer.
- Currently enrolled in an investigational drug trial.
- Woman of child bearing potential not utilizing an effective form of birth control.
- Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or serum fasting triglycerides >500 mg/dL.
- Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram of creatinine.
- WBC < 2,000 cells/mm3
- Platelets < 75,000 cells/mm3
- Patients who have received an organ transplant other than a kidney.
- Patients with a history of biopsy proven FSGS, MPGN, or PGN.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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