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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

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ClinicalTrials.gov Identifier: NCT01681134
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : November 8, 2012
Information provided by (Responsible Party):

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
Healthy Drug: Advagraf® Drug: Prograf® 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  (Clinical Trial)
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 : July 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Advagraf followed by Prograf Drug: Advagraf®
Other Name: tacrolimus XL, FK506E
Drug: Prograf®
Other Name: tacrolimus, FK506
Experimental: Prograf followed by Advagraf Drug: Advagraf®
Other Name: tacrolimus XL, FK506E
Drug: Prograf®
Other Name: tacrolimus, FK506

Outcome Measures

Primary Outcome Measures :
  1. Effective Renal Plasma Flow (ERPF) [ Time Frame: up to Day 20 ]
    Estimated by aminohippurate sodium (PAH) clearance

Secondary Outcome Measures :
  1. Glomerular Filtration Rate (GFR) [ Time Frame: Pre-dose (Day -4), Day 10, Day 20 ]
    Estimated by sinistrin clearance

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681134

Canada, Ontario
INC Research
Toronto, Ontario, Canada, M5V 2T3
Sponsors and Collaborators
Astellas Pharma Canada, Inc.
Study Director: Associate Director, Medical Affairs Astellas Pharma Canada, Inc.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Canada, Inc.
ClinicalTrials.gov Identifier: NCT01681134     History of Changes
Other Study ID Numbers: FKC-016
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: November 8, 2012
Last Verified: November 2012

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Canada, Inc. ):
Glomerular Filtration Rate
Effective Renal Plasma Flow

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action