NCT01976390

Comparing Everolimus and Sirolimus in Renal Transplant Recipients

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Failure

Interventions

Type	Name	Description
DRUG	Everolimus	0.75mg twice a day, Orally, starting on day of transplant
DRUG	Sirolimus	5mg, Orally, starting on day of transplant; decreasing to 3mg

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-07-11
• Completion: 2019-08-31
• First posted: 2013-11-05
• Last updated: 2022-10-21
• Results posted: 2021-11-30

Locations

1 site across 1 country: United States