Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
- Conditions
- Immunosuppression
- Interventions
- Registration Number
- NCT02953873
- Lead Sponsor
- Medical University of South Carolina
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Conversion Arm Tacrolimus Extended Release Capsule Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily Conversion Arm Mycophenolate Sodium Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily Conversion Arm Mycophenolate mofetil Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily Conversion Arm Prednisone Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily
- Primary Outcome Measures
Name Time Method Dose-normalized Trough Baseline to 3 months post-conversion Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL®
- Secondary Outcome Measures
Name Time Method Weight-Based Dose Requirement Baseline to 3 months post conversion Weight-based dose requirements to reach therapeutic goal pre- and post-conversion
Dose Modifications Baseline to 3 months post conversion Number of dose modifications from baseline to 3 months post-conversion.
Total Daily Dose Baseline to 3 months post conversion Difference in Total Daily Dose necessary for steady state therapeutic goal
Number of Days to Reach Therapeutic Trough Goal Baseline to 3 months post conversion Days to reach therapeutic goal after conversion
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States