| Title: | Heart Transplant Medication Study |
| Purpose: | The purpose of this study is to test the safety and effectiveness of Certican combined with Neoral in patients with new heart transplants. The study will compare this new regimen with a commonly used regimen, MMF plus Neoral. |
| Study Number: | 108595 |
| Number of Patients: | 630 |
| Elgibility: |
To qualify for this trial, patients must be undergoing a heart transplant for the first time. Patients will be between 18 and 70 years of age. Common exclusion criteria include infection at the time of transplant, low blood count and patients that receive multiple organ transplants at one time.
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| Treatment: | Patients will begin the study within 72 hours after receiving their heart transplant. Patients will be randomized to one of three treatment options: MMF plus Neoral, Certican plus Neoral (level 1) or Certican plus Neoral (level 2). Lab tests, EKG and a physical exam are required to determine eligibility. After a patient begins the study drug treatment, vitals will be obtained and lab tests will be performed at every visit. Sixteen visits are required following the start of the study. These visits will follow the standard heart transplant visit schedule here at Loyola. Patients will receive their study drugs for 24 months after heart transplant. |
| Principal Investigator: |
Alain Heroux, M.D. |
| Enrollment Phone: | (708) 327-2723 |
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