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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Canada, Inc. )
ClinicalTrials.gov Identifier:
NCT01681134
First received: September 5, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Advagraf®
Drug: Prograf®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Effective Renal Plasma Flow (ERPF) [ Time Frame: up to Day 20 ] [ Designated as safety issue: No ]
    Estimated by aminohippurate sodium (PAH) clearance


Secondary Outcome Measures:
  • Glomerular Filtration Rate (GFR) [ Time Frame: Pre-dose (Day -4), Day 10, Day 20 ] [ Designated as safety issue: No ]
    Estimated by sinistrin clearance


Enrollment: 19
Study Start Date: July 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advagraf followed by Prograf Drug: Advagraf®
oral
Other Name: tacrolimus XL, FK506E
Drug: Prograf®
oral
Other Name: tacrolimus, FK506
Experimental: Prograf followed by Advagraf Drug: Advagraf®
oral
Other Name: tacrolimus XL, FK506E
Drug: Prograf®
oral
Other Name: tacrolimus, FK506

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681134

Locations
Canada, Ontario
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.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Canada, Inc. )
ClinicalTrials.gov Identifier: NCT01681134     History of Changes
Other Study ID Numbers: FKC-016
Study First Received: September 5, 2012
Last Updated: November 6, 2012
Health Authority: Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
tacrolimus
Advagraf®
Prograf®
Glomerular Filtration Rate
Effective Renal Plasma Flow
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014