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

Completed · Phase 4

Conditions studied: Immunosuppression

In brief

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.

Key facts

Study ID

NCT02953873

Run by

Medical University of South Carolina

People needed

25

Starts

2017-05-05

Expected to finish

2018-12-14

Last updated by the study team

2019-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Signed informed consent
• African American race
• History of a solitary renal transplant
• Stable tacrolimus dose for at least 2 weeks prior to randomization

You may not qualify if…

• 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
• Currently enrolled in an investigational drug trial
• History of a non-renal organ transplant
• History of acute cellular rejection within 1 month prior to randomization
• An increase in serum creatinine by > 20% in the 2 weeks prior to randomization
• 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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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