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A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers

NCT ID: NCT01681134

Last Updated: 2012-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.

Detailed Description

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This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10 days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the monitoring of drug levels in blood.

Conditions

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Healthy

Keywords

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tacrolimus Advagraf® Prograf® Glomerular Filtration Rate Effective Renal Plasma Flow Pharmacokinetics Pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Advagraf followed by Prograf

Group Type EXPERIMENTAL

Advagraf®

Intervention Type DRUG

oral

Prograf®

Intervention Type DRUG

oral

Prograf followed by Advagraf

Group Type EXPERIMENTAL

Advagraf®

Intervention Type DRUG

oral

Prograf®

Intervention Type DRUG

oral

Interventions

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Advagraf®

oral

Intervention Type DRUG

Prograf®

oral

Intervention Type DRUG

Other Intervention Names

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tacrolimus XL, FK506E tacrolimus, FK506

Eligibility Criteria

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Inclusion Criteria

* Caucasian
* No previous/current history of infection, cerebrovascular, neurological, cardiovascular, endocrine, pulmonary, immunologic or metabolic disease or significant systemic disease, glucose intolerance, gout or hematological disorder
* Normal 12-lead Electrocardiogram (ECG)
* Systolic blood pressure \<140 mm Hg and diastolic blood pressure \<90 mm Hg
* Non-smoker within 3 months prior to screening
* Willing to abstain from alcohol during the study

Exclusion Criteria

* Positive screen for illicit drug or alcohol consumption
* Subject has hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or history of cancer (excluding completely excised squamous or basal cell carcinoma)
* Positive tuberculin skin test or known history of tuberculosis infection
* Known history of serious head injuries, seizures or eating disorders
* Body Mass Index \<18.0 or \>30.0
* History of renal dysfunction, clinically significant creatinine or clinically significant abnormal liver function tests, hemoglobin \<130 g/L
* Plasma donation ≥ 500 mL within 7 days prior to first dose of study drug, donation or whole blood loss 50-499 mL within 30 days or ≥ 499 mL within 56 days prior to first dose of study drug.
* Drug or alcohol abuse within 1 year prior to study entry
* Steroid injections within 12 weeks prior to first dose of study drug
* Live vaccine within 7 days prior to first dose of study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Canada, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Associate Director, Medical Affairs

Role: STUDY_DIRECTOR

Astellas Pharma Canada, Inc.

Locations

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INC Research

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Zaltzman JS, Lai V, Schulz MZ, Moon KH, Cherney DZ. A randomized cross-over comparison of short-term exposure of once-daily extended release tacrolimus and twice-daily tacrolimus on renal function in healthy volunteers. Transpl Int. 2014 Dec;27(12):1294-302. doi: 10.1111/tri.12435. Epub 2014 Sep 29.

Reference Type DERIVED
PMID: 25160518 (View on PubMed)

Other Identifiers

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FKC-016

Identifier Type: -

Identifier Source: org_study_id