Novartis Everolimus Transition

Phase 4CompletedNCT02096107

Medical University of South Carolina60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Graft Dysfunction Interstitial Fibrosis

Interventions

EverolimusDRUG

Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus

Standard of CareOTHER

Tacrolimus, mycophenolate mofetil and steroids

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Kidney Allograft Fibrosis Assessment

Measure and compare the change in interstitial fibrosis (morphometric analysis of trichrome stained slides) at one-year post-transplant in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen. The scale is a percentage of the tissue that demonstrates fibrosis. The scale range is 0 to 100%. The higher the percentage, the worse the fibrosis and the poorer the prognosis. A lower score (percentage) is therefore better.

Time frame: 1 year

Secondary Outcomes

Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR)

Measure and compare the estimated GFR (using the 4-variable modified MDRD equation) in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen, both at one year and two years post-transplant.

Time frame: 1 year

Kidney Allograft Survival

Compare the patient and graft survival rates at one-year post-transplant in each group.

Time frame: 1 year

Percentage of Participants Discontinuing or Modifying Immunosuppressant Use

Measure and compare the rates of immunosuppressant discontinuation and modification for each group.

Time frame: 2 year

Adverse Drug Reactions

Measure and compare the incidence of significant immunosuppressant-related adverse drug reactions for each group.

Time frame: 2 year

Infection

Compare the rates of post-transplant infections, including CMV, BK, and admissions to the hospital for infectious causes in each group.

Data from ClinicalTrials.gov

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