Back to resultsComparing Everolimus and Sirolimus in Renal Transplant Recipients
Primary Purpose
Renal Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Everolimus
Sirolimus
Sponsored by
About this trial
This is an interventional prevention trial for Renal Failure focused on measuring Kidney, Kidney transplant, Renal failure, End Stage Renal Disease, kidney transplant recipient
Eligibility Criteria
Inclusion Criteria:
- Patients must give written informed consent before any assessment is performed.
- Primary renal transplant recipients between ages 18 and 75 years of age.
- Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation and practice an effective form of birth control for the duration of the study and 12 weeks after discontinuation of the study drug if applicable.
Exclusion Criteria:
- Total cholesterol > 300 mg/dl or triglycerides > 400 mg/dl despite lipid lowering therapy
- Pre-existing bone marrow suppression (White Blood Cell count of < 3000, platelets < 100,000)
- Active infection (Hepatitis B Virus, HIV)
- Malignancy (except for adequately treated squamous or basal cell skin carcinoma) unless patient has written clearance from an Oncologist or if patient has had no malignancy for at least 2 years prior to the transplant
- Allergy or intolerance to Zortress, Rapamune, cyclosporine, or Anti-thymocyte globulin
Sites / Locations
- The Ohio State University Wexner Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Zortress (Everolimus)
Rapamune (Sirolimus)
Arm Description
Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral.
Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.
Outcomes
Primary Outcome Measures
Number of Participants With Composite Endpoint of Graft Survival (Non-death Censored) and Biopsy Proven Acute Rejection at 1 Year
The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at 1 year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above.
Secondary Outcome Measures
Full Information
NCT ID
NCT01976390
First Posted
October 20, 2013
Last Updated
October 19, 2022
Sponsor
Ohio State University
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01976390
Brief Title
Comparing Everolimus and Sirolimus in Renal Transplant Recipients
Official Title
A Prospective, Randomized, Single Center Pilot Study Comparing Patient and Graft Survival, Adverse Events and Tolerability of Zortress® (Everolimus) Versus Rapamune® (Sirolimus) in Combination With Low Dose Neoral® (Cyclosporine) Dosed by C2 Monitoring, in Deceased and Living Donor Renal Transplant Recipients Under a Thymoglobulin® (Antithymocyte Globulin) and Rapid Steroid Induction Protocol.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in the current standard immunosuppression regimen).
Detailed Description
Zortress is FDA approved, is used as standard of care at some other institutions, and may also be given as standard of care if it is believed to be the best immunosuppression regimen for a particular kidney transplant recipient. The rationale for testing Zortress vs. Rapamune is to determine which of these drugs is more effective in preventing chronic rejection of the transplanted kidney. Because these two drugs are related to each other there is no current literature addressing the replacement of Rapamune with Zortress in an immunosuppression regimen, therefore the goal of this study is to compare these two immunosuppression drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Kidney, Kidney transplant, Renal failure, End Stage Renal Disease, kidney transplant recipient
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zortress (Everolimus)
Arm Type
Active Comparator
Arm Description
Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral.
Arm Title
Rapamune (Sirolimus)
Arm Type
Active Comparator
Arm Description
Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
Zortress
Intervention Description
0.75mg twice a day, Orally, starting on day of transplant
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Rapamune
Intervention Description
5mg, Orally, starting on day of transplant; decreasing to 3mg
Primary Outcome Measure Information:
Title
Number of Participants With Composite Endpoint of Graft Survival (Non-death Censored) and Biopsy Proven Acute Rejection at 1 Year
Description
The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at 1 year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must give written informed consent before any assessment is performed.
Primary renal transplant recipients between ages 18 and 75 years of age.
Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation and practice an effective form of birth control for the duration of the study and 12 weeks after discontinuation of the study drug if applicable.
Exclusion Criteria:
Total cholesterol > 300 mg/dl or triglycerides > 400 mg/dl despite lipid lowering therapy
Pre-existing bone marrow suppression (White Blood Cell count of < 3000, platelets < 100,000)
Active infection (Hepatitis B Virus, HIV)
Malignancy (except for adequately treated squamous or basal cell skin carcinoma) unless patient has written clearance from an Oncologist or if patient has had no malignancy for at least 2 years prior to the transplant
Allergy or intolerance to Zortress, Rapamune, cyclosporine, or Anti-thymocyte globulin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amer Rajab, MD
Organizational Affiliation
OSU Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Everolimus and Sirolimus in Renal Transplant Recipients
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