NCT02953873

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

Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to compare the difference in medication dosage and total daily dose necessary of Astagraf XL® in order to reach therapy goal, when taken with other medications that are routinely used for kidney transplantation, which may stop the development of a substance that can cause long-term damage to the transplanted kidney. African American kidney transplant patients aged 18 and above who are underwent a kidney transplant are eligible to participate. The duration of the study is 3 months.

Conditions

• Immunosuppression

Interventions

Type	Name	Description
DRUG	Tacrolimus Extended Release Capsule	goal trough 5 - 12ng/mL
DRUG	Mycophenolate mofetil	≥500mg twice a day
DRUG	Prednisone	goal dose 5mg daily
DRUG	Mycophenolate Sodium	≥360mg twice a day

Timeline

• Start date: 2017-05-05
• Primary completion: 2018-09-10
• Completion: 2018-12-14
• First posted: 2016-11-03
• Last updated: 2019-12-26
• Results posted: 2019-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study