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Novartis Everolimus Transition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02096107
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Medical University of South Carolina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Graft Dysfunction Interstitial Fibrosis Drug: Everolimus Other: Standard of Care Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Everolimus Transition in Minimizing Progressive Graft Dysfunction and Interstitial Fibrosis in Adult Kidney Transplant Recipients
Actual Study Start Date : February 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Low intensity Tacrolimus
Low tacrolimus, everolimus, and steroids
 Drug: Everolimus
Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus
Standard of Care
Tacrolimus, mycophenolate mofetil and steroids
 Other: Standard of Care
Tacrolimus, mycophenolate mofetil and steroids


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096107


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Novartis
Investigators
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Principal Investigator: Titte Srinivas, MD Medical University of South Carolina
Principal Investigator: David Taber Medical University of South Carolina, Department of Surgery
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
Study Protocol and Statistical Analysis Plan  [PDF] September 30, 2013

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02096107    
Other Study ID Numbers: Pro00030099
First Posted: March 26, 2014    Key Record Dates
Results First Posted: August 8, 2018
Last Update Posted: August 8, 2018
Last Verified: July 2018
Keywords provided by Medical University of South Carolina:
Everolimus
Graft dysfunction
Interstitial fibrosis
Additional relevant MeSH terms:
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Lung Diseases, Interstitial
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
 Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs