This trial is active, not recruiting.

Condition renal failure
Treatments everolimus, sirolimus
Targets mTOR, FKBP-12
Sponsor Dr.Ronald Pelletier
Collaborator Novartis
Start date February 2014
End date February 2017
Trial size 60 participants
Trial identifier NCT01976390, 2013H0229


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
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.
everolimus Zortress
0.75mg twice a day, Orally, starting on day of transplant
(Active Comparator)
Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.
sirolimus Rapamune
5mg, Orally, starting on day of transplant; decreasing to 3mg

Primary Outcomes

Graft Survival Comparison of Zortress vs. Rapamune
time frame: 1 Year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Patients must give written informed consent before any assessment is performed. 2. Primary renal transplant recipients between ages 18 and 75 years of age. 3. 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: 1. Total cholesterol > 300 mg/dl or triglycerides > 400 mg/dl despite lipid lowering therapy 2. Pre-existing bone marrow suppression (White Blood Cell count of < 3000, platelets < 100,000) 3. Active infection (Hepatitis B Virus, HIV) 4. 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 5. Allergy or intolerance to Zortress, Rapamune, cyclosporine, or Anti-thymocyte globulin

Additional Information

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.
Principal investigator Ronald Pelletier, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Ohio State University.