Clinical trial NCT02096107: Novartis Everolimus Transition
Official title: Safety and Efficacy of Everolimus Transition in Minimizing Progressive Graft Dysfunction and Interstitial Fibrosis in Adult Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Graft Dysfunction
Interstitial Fibrosis
Keywords: Everolimus
Graft dysfunction
Interstitial fibrosis
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2014-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

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.

Primary outcomes:
measure: Kidney Allograft Fibrosis Assessment
timeFrame: 1 year
Secondary outcomes:
measure: Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR)
timeFrame: 1 year
measure: Kidney Allograft Survival
timeFrame: 1 year
measure: Percentage of Participants Discontinuing or Modifying Immunosuppressant Use
timeFrame: 2 year
measure: Adverse Drug Reactions
timeFrame: 2 year
measure: Infection
timeFrame: 2 year
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Titte Srinivas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina, Department of Surgery
name: David Taber
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taber DJ, Chokkalingam A, Su Z, Self S, Miller D, Srinivas T. Randomized controlled trial assessing the impact of everolimus and low-exposure tacrolimus on graft outcomes in kidney transplant recipients. Clin Transplant. 2019 Oct;33(10):e13679. doi: 10.1111/ctr.13679. Epub 2019 Sep 12.