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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Immunosuppression

Intervention / Treatment
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* Drug: Tacrolimus Extended Release Capsule
* Drug: Mycophenolate mofetil
* Drug: Prednisone
* Drug: Mycophenolate Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conversion Arm<br>Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily | Drug: Tacrolimus Extended Release Capsule<br>* goal trough 5 - 12ng/mL<br>* Other names: Astagraf XL;Drug: Mycophenolate mofetil<br>* ≥500mg twice a day<br>* Other names: Cellcept;Drug: Prednisone<br>* goal dose 5mg daily<br>* Other names: Methylprednisolone;Drug: Mycophenolate Sodium<br>* ≥360mg twice a day<br>* Other names: Myfortic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-normalized Trough | Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL® | Baseline to 3 months post-conversion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Daily Dose | Difference in Total Daily Dose necessary for steady state therapeutic goal | Baseline to 3 months post conversion | 
| Weight-Based Dose Requirement | Weight-based dose requirements to reach therapeutic goal pre- and post-conversion | Baseline to 3 months post conversion | 
| Number of Days to Reach Therapeutic Trough Goal | Days to reach therapeutic goal after conversion | Baseline to 3 months post conversion | 
| Dose Modifications | Number of dose modifications from baseline to 3 months post-conversion. | Baseline to 3 months post conversion |