Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2018-12-14
• Target enrollment: 0
• Participant gender: All

Summary

Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.

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

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: Astellas Pharma Inc
• Treatments: Methylprednisolone; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

1. At least 18 years of age

2. Signed informed consent

3. African American race

4. History of a solitary renal transplant

5. Stable tacrolimus dose for at least 2 weeks prior to randomization

Exclusion Criteria:

1. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject

2. Currently enrolled in an investigational drug trial

3. History of a non-renal organ transplant

4. History of acute cellular rejection within 1 month prior to randomization

5. An increase in serum creatinine by > 20% in the 2 weeks prior to randomization

6. Maintenance immunosuppression that does not consist of tacrolimus IR given twice daily, mycophenolate mofetil > 1000mg TDD or mycophenolate sodium > 720mg TDD, and prednisone ≥ 5mg daily