Comparing Everolimus and Sirolimus in Renal Transplant Recipients

NCT ID: NCT01976390

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2019-08-31

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.

Conditions

Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Everolimus

Intervention Type: DRUG

0.75mg twice a day, Orally, starting on day of transplant

Rapamune (Sirolimus)

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

Group Type: ACTIVE_COMPARATOR

Sirolimus

Intervention Type: DRUG

5mg, Orally, starting on day of transplant; decreasing to 3mg

Interventions

Everolimus

0.75mg twice a day, Orally, starting on day of transplant

Intervention Type: DRUG

Sirolimus

5mg, Orally, starting on day of transplant; decreasing to 3mg

Intervention Type: DRUG

Other Intervention Names

Zortress; Rapamune

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amer Rajab, MD

Role: PRINCIPAL_INVESTIGATOR

OSU Wexner Medical Center

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2013H0229

Identifier Type: -

Identifier Source: org_study_id