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

November 6, 2012 updated by: Astellas Pharma Canada, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5V 2T3
        • INC Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective Renal Plasma Flow (ERPF)
Time Frame: up to Day 20
Estimated by aminohippurate sodium (PAH) clearance
up to Day 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular Filtration Rate (GFR)
Time Frame: Pre-dose (Day -4), Day 10, Day 20
Estimated by sinistrin clearance
Pre-dose (Day -4), Day 10, Day 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Canada, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (ESTIMATE)

September 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2012

Last Update Submitted That Met QC Criteria

November 6, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKC-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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