Comparing Everolimus and Sirolimus in Renal Transplant Recipients

The Ohio State University

Status: Completed

Conditions: Renal Failure

Treatments: Drug: Everolimus; Drug: Sirolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01976390

2013H0229

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Zortress (Everolimus)

Active Comparator group

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.

Treatment:

Drug: Everolimus

Rapamune (Sirolimus)

Active Comparator group

Description:

Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.

Treatment:

Drug: Sirolimus