Novartis Everolimus Transition

NCT02096107 | Completed Phase 4 Results

• 1 other identifier: Pro00030099
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Dysfunction; Interstitial Fibrosis

Keywords

Everolimus; Graft dysfunction; Interstitial fibrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (5)

• Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR)

  1 year

• Kidney Allograft Survival

  1 year

• Percentage of Participants Discontinuing or Modifying Immunosuppressant Use

  2 year

• Adverse Drug Reactions

  2 year

• Infection

  2 year

Study Arms (2)

Low intensity Tacrolimus

ACTIVE COMPARATOR

Low tacrolimus, everolimus, and steroids

Drug: Everolimus

Standard of Care

OTHER

Tacrolimus, mycophenolate mofetil and steroids

Other: Standard of Care

Interventions

Everolimus DRUG

Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus

Low intensity Tacrolimus

Standard of Care OTHER

Tacrolimus, mycophenolate mofetil and steroids

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Novartis: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 31365151 DERIVED

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

Everolimus; Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: David Taber
• Organization: Medical University of South Carolina

taberd@musc.edu

843-792-3368

Study Officials

• Titte Srinivas, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• David Taber

  Medical University of South Carolina, Department of Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 26, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 8, 2018
• Results First Posted: August 8, 2018

Record last verified: 2018-07

Locations

US (1)