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
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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014