Comparing Everolimus and Sirolimus in Renal Transplant Recipients

• Status: Unknown status
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr.Ronald Pelletier
• Collaborator: Novartis
• Treatments: Everolimus; Sirolimus

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