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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

Sponsor
Astellas Pharma Canada, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01681134
Collaborator
(none)
19
Enrollment
1
Location
2
Arms
3
Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
A Comparison of Effects of Short-Term Steady State Low Dose Exposure of Extended Release (Advagraf®) and Immediate Release (Prograf®) Formulations of Tacrolimus on Renal Perfusion and Function in Healthy Male Volunteers
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Advagraf followed by Prograf

Drug: Advagraf®
oral
Other Names:
  • tacrolimus XL, FK506E

    • Drug: Prograf®
    oral
    Other Names:
  • tacrolimus, FK506

    		•
    Experimental: Prograf followed by Advagraf

    Drug: Advagraf®
    oral
    Other Names:
  • tacrolimus XL, FK506E

    • Drug: Prograf®
    oral
    Other Names:
  • tacrolimus, FK506

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effective Renal Plasma Flow (ERPF) [up to Day 20]

      Estimated by aminohippurate sodium (PAH) clearance

    Secondary Outcome Measures

    1. Glomerular Filtration Rate (GFR) [Pre-dose (Day -4), Day 10, Day 20]

      Estimated by sinistrin clearance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 INC Research Toronto Ontario Canada M5V 2T3

    Sponsors and Collaborators

    • Astellas Pharma Canada, Inc.

    Investigators

    • Study Director: Associate Director, Medical Affairs, Astellas Pharma Canada, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Canada, Inc.
    ClinicalTrials.gov Identifier:
    NCT01681134
    Other Study ID Numbers:
    • FKC-016
    First Posted:
    Sep 7, 2012
    Last Update Posted:
    Nov 8, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Astellas Pharma Canada, Inc.
    tacrolimus
    Advagraf®
    Prograf®
    Glomerular Filtration Rate
    Effective Renal Plasma Flow
    Pharmacokinetics
    Pharmacodynamics
    Additional relevant MeSH terms:
    Tacrolimus

    Study Results

    No Results Posted as of Nov 8, 2012