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

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.

Study Overview

• Status: Completed
• Conditions: Immunosuppression
• Intervention / Treatment: Drug: Tacrolimus Extended Release Capsule; Drug: Mycophenolate mofetil; Drug: Prednisone; Drug: Mycophenolate Sodium

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conversion Arm; 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; goal trough 5 - 12ng/mL; Other Names: Astagraf XL; Drug: Mycophenolate mofetil; ≥500mg twice a day; Other Names: Cellcept; Drug: Prednisone; goal dose 5mg daily; Other Names: Corticosteroids; Methylprednisolone; Drug: Mycophenolate Sodium; ≥360mg twice a day; Other Names: Myfortic

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Astellas Pharma Inc
• Investigators: Principal Investigator: James Fleming, PharmD, Medicual U of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 3, 2016

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Methylprednisolone; Prednisone; Tacrolimus; Mycophenolic Acid
• Other Study ID Numbers: 00061221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No