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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681134
• Other study ID #: FKC-016
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2012
• Last updated: November 6, 2012
• Start date: July 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Advagraf®
oral
• Prograf®
oral

Locations

Country	Name	City	State
Canada	INC Research	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Canada, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Renal Plasma Flow (ERPF)	Estimated by aminohippurate sodium (PAH) clearance	up to Day 20	No
Secondary	Glomerular Filtration Rate (GFR)	Estimated by sinistrin clearance	Pre-dose (Day -4), Day 10, Day 20	No