Phase 4
N=60
Novartis Everolimus Transition
Graft Dysfunction · Interstitial Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02096107 ↗Enrolled (actual)
60
Serious AEs
23.3%
Results posted
Aug 2018
Primary outcome: Primary: Kidney Allograft Fibrosis Assessment — 22.9; 20.8; 22.9; 27.8 % of fibrosis
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Everolimus (Drug); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kidney Allograft Fibrosis Assessment |
22.9; 20.8; 22.9; 27.8 | — |
| SECONDARY Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR) |
59; 56 | — |
| SECONDARY Kidney Allograft Survival |
100; 100 | — |
| SECONDARY Percentage of Participants Discontinuing or Modifying Immunosuppressant Use |
37; 20 | — |
| SECONDARY Adverse Drug Reactions |
11; 6 | — |
| SECONDARY Infection |
17; 30 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02096107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.