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

Immunosuppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953873
• Other study ID #: 00061221
• Status: Completed
• Phase: Phase 4
• Start date: May 5, 2017
• Est. completion date: December 14, 2018

Study information

• Verified date: December 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 14, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunosuppression

Intervention

Drug:
• Tacrolimus Extended Release Capsule
goal trough 5 - 12ng/mL
• Mycophenolate mofetil
=500mg twice a day
• Prednisone
goal dose 5mg daily
• Mycophenolate Sodium
=360mg twice a day

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

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