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Completed

NCT Number: NCT02096107

Novartis Everolimus Transition

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.

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Key information

Conditions

Graft Dysfunction Fibrosis Interstitial Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Everolimus

Drug

Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus

Standard of care

Other

Tacrolimus, mycophenolate mofetil and steroids

Primary outcomes

  1. Kidney Allograft Fibrosis Assessment

    Time frame: 1 year

    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.

Secondary outcomes

  1. Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 1 year

    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.

  2. Kidney Allograft Survival

    Time frame: 1 year

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

  3. Percentage of Participants Discontinuing or Modifying Immunosuppressant Use

    Time frame: 2 year

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

  4. Adverse Drug Reactions

    Time frame: 2 year

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

  5. Infection

    Time frame: 2 year

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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Novartis

Registry information

Official study title

Safety and Efficacy of Everolimus Transition in Minimizing Progressive Graft Dysfunction and Interstitial Fibrosis in Adult Kidney Transplant Recipients

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2014
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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