Novartis Everolimus Transition

Graft Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096107
• Other study ID #: Pro00030099
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: May 2017

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Graft Dysfunction
• Interstitial Fibrosis
• Lung Diseases, Interstitial

Intervention

Drug:
• Everolimus
Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus

Other:
• Standard of Care
Tacrolimus, mycophenolate mofetil and steroids

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year
Secondary	Kidney Allograft Survival	Compare the patient and graft survival rates at one-year post-transplant in each group.	1 year
Secondary	Percentage of Participants Discontinuing or Modifying Immunosuppressant Use	Measure and compare the rates of immunosuppressant discontinuation and modification for each group.	2 year
Secondary	Adverse Drug Reactions	Measure and compare the incidence of significant immunosuppressant-related adverse drug reactions for each group.	2 year
Secondary	Infection	Compare the rates of post-transplant infections, including CMV, BK, and admissions to the hospital for infectious causes in each group.	2 year