Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 5, 2012
November 6, 2012
July 2012
October 2012   (final data collection date for primary outcome measure)
Effective Renal Plasma Flow (ERPF) [ Time Frame: up to Day 20 ] [ Designated as safety issue: No ]
Estimated by aminohippurate sodium (PAH) clearance
Same as current
Complete list of historical versions of study NCT01681134 on ClinicalTrials.gov Archive Site
Glomerular Filtration Rate (GFR) [ Time Frame: Pre-dose (Day -4), Day 10, Day 20 ] [ Designated as safety issue: No ]
Estimated by sinistrin clearance
Same as current
Not Provided
Not Provided
 
A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Advagraf®
    oral
    Other Name: tacrolimus XL, FK506E
  • Drug: Prograf®
    oral
    Other Name: tacrolimus, FK506
  • Experimental: Advagraf followed by Prograf
    Interventions:
    • Drug: Advagraf®
    • Drug: Prograf®
  • Experimental: Prograf followed by Advagraf
    Interventions:
    • Drug: Advagraf®
    • Drug: Prograf®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01681134
FKC-016
No
Astellas Pharma Inc ( Astellas Pharma Canada, Inc. )
Astellas Pharma Canada, Inc.
Not Provided
Study Director: Associate Director, Medical Affairs Astellas Pharma Canada, Inc.
Astellas Pharma Inc
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP