Cardiovascular Risk Following Conversion to Full Dose Myfortic® and Neoral® Two-hour Post Level Monitoring

• Status: Withdrawn
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall goal of this study is to improve cardiovascular outcomes in transplant recipients. The current standard immunosuppressive regimen in kidney transplant recipients depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to investigate the effects of reversing this paradigm. More specifically, the effect of using maximum MPA dosages (in the form of enteric-coated mycophenolate sodium [EC-MPS] or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid; Prednisone

Criteria

Inclusion Criteria:

1. Kidney transplant patients followed as outpatients who are currently stabilized on immunosuppressive therapy with an MPA derivative, a CNI and prednisone where stability is defined as change in serum creatinine of less than 10% or over the last three months.

2. Age 18-74 years old.

3. At least six months after transplantation.

4. Lack of transplant rejection within the last 12 weeks.

5. Serum creatinine less than 300 umol/L at enrolment.

6. Negative urine pregnancy test for female patients of childbearing potential.

7. Consent to the study.

8. Not included in another interventional clinical trial within the last 90 days.

Exclusion Criteria:

1. Patients with other types of solid organ transplants.

2. Patients with any form of substance abuse or major psychiatric disorder.

3. Patients with acute or chronic diarrhea, known bowel disease or known gastroparesis.

4. Patients receiving anti-lymphocyte treatment for rejection within the last six months.

5. Patients not receiving a mycophenolic acid derivative.

6. Patients who do not tolerate the maximum Myfortic® total daily dose of 1440 mg OD.

7. Patients with significant liver disease defined as having an elevated bilirubin by at least two times the upper value of the normal range.

8. Patients who have any unstable medical condition that could interfere with the study.

9. Patients with chronic viral infection with HIV, Hepatitis B & C.

10. Presence of any acute illness requiring admission to the hospital for the last 4 weeks.

11. Pregnancy.

12. Significant cardiovascular event such as MI, stroke or TIA within the last 12 weeks or uncontrolled hypertension.

13. Immunosuppressant changes within the last month.