Comparing Everolimus and Sirolimus in Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT01976390|
Recruitment Status : Unknown
Verified May 2017 by Dr.Ronald Pelletier, Ohio State University.
Recruitment status was: Active, not recruiting
First Posted : November 5, 2013
Last Update Posted : May 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure||Drug: Everolimus Drug: Sirolimus||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2014|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
Active Comparator: Zortress (Everolimus)
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.
0.75mg twice a day, Orally, starting on day of transplant
Other Name: Zortress
Active Comparator: Rapamune (Sirolimus)
Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.
5mg, Orally, starting on day of transplant; decreasing to 3mg
Other Name: Rapamune
- Graft Survival Comparison of Zortress vs. Rapamune [ Time Frame: 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.
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): NCT01976390
|United States, Ohio|
|The Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43212|
|Principal Investigator:||Ronald Pelletier, MD||OSU Wexner Medical Center|