Sirolimus Conversions in African-American Renal Transplant Recipients

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study's focus is to compare the level effectiveness and safety of regimens involving Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American recipients of kidney transplants.

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

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• At least 18 years of age and able to give informed consent

• African-American ethnicity

• Received a first or second non-ECD cadaveric or living donor renal transplant

• Transplant occurred during the past 6 to 24 weeks

• Patient has stable graft function, defined as no change of greater than 30% of baseline serum creatinine during the past month and no acute rejection in the past 6 weeks

• Estimated GFR using the modified MDRD equation of at least 40 mL/min10 at time of enrollment into the study

• Currently receiving tacrolimus, mycophenolate mofetil (at least 1 gm per day), and corticosteroids as their immunosuppression regimen.

Exclusion Criteria:

• Biopsy proven acute rejection episode that occurred within the past 6 weeks

• Malignancy within the past 3 years, except for non-melanoma skin cancer

• Any known intolerances to current immunosuppressant regimen necessitating withdrawal of the offending agent

• Currently enrolled in an investigational trial

• Woman of child bearing potential not utilizing an effective form of birth control

• Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or serum fasting triglycerides >500 mg/dL.

• Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram of creatinine.

• WBC < 3,000 cells/mm3

• Platelets < 100,000 cells/mm3