Novartis Everolimus Transition

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 4

Conditions: Graft Dysfunction; Interstitial Fibrosis

Treatments: Drug: Everolimus; Other: Standard of Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02096107

Pro00030099

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Low intensity Tacrolimus

Active Comparator group

Description:

Low tacrolimus, everolimus, and steroids

Treatment:

Drug: Everolimus

Standard of Care

Other group

Description:

Tacrolimus, mycophenolate mofetil and steroids

Treatment:

Other: Standard of Care