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

NCT ID: NCT02953873

Last Updated: 2019-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2018-12-14

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.

Conditions

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Immunosuppression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Tacrolimus Extended Release Capsule

Intervention Type DRUG

goal trough 5 - 12ng/mL

Mycophenolate mofetil

Intervention Type DRUG

≥500mg twice a day

Prednisone

Intervention Type DRUG

goal dose 5mg daily

Mycophenolate Sodium

Intervention Type DRUG

≥360mg twice a day

Interventions

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Tacrolimus Extended Release Capsule

goal trough 5 - 12ng/mL

Intervention Type DRUG

Mycophenolate mofetil

≥500mg twice a day

Intervention Type DRUG

Prednisone

goal dose 5mg daily

Intervention Type DRUG

Mycophenolate Sodium

≥360mg twice a day

Intervention Type DRUG

Other Intervention Names

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Astagraf XL Cellcept Corticosteroids Methylprednisolone Myfortic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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James N. Fleming

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Fleming, PharmD

Role: PRINCIPAL_INVESTIGATOR

Medicual U of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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00061221

Identifier Type: -

Identifier Source: org_study_id