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

NCT02953873 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-12-26

Study results available
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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.

Conditions

  • Immunosuppression

Interventions

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

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • James Fleming, PharmD · Medicual U of South Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2018-09-10
Completion
2018-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02953873 on ClinicalTrials.gov