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

NCT01681134 | Completed Phase 1

• 1 other identifier: FKC-016
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

tacrolimus; Advagraf®; Prograf®; Glomerular Filtration Rate; Effective Renal Plasma Flow; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Effective Renal Plasma Flow (ERPF)

  Estimated by aminohippurate sodium (PAH) clearance

  up to Day 20

Secondary Outcomes (1)

• Glomerular Filtration Rate (GFR)

  Pre-dose (Day -4), Day 10, Day 20

Study Arms (2)

Advagraf followed by Prograf

EXPERIMENTAL

Drug: Advagraf®; Drug: Prograf®

Prograf followed by Advagraf

EXPERIMENTAL

Drug: Advagraf®; Drug: Prograf®

Interventions

Advagraf® DRUG

oral

Also known as: tacrolimus XL, FK506E

Advagraf followed by Prograf; Prograf followed by Advagraf

Prograf® DRUG

oral

Also known as: tacrolimus, FK506

Advagraf followed by Prograf; Prograf followed by Advagraf

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Canada, Inc.: lead

Study Sites (1)

INC Research

Toronto, Ontario, M5V 2T3, Canada

Location

Related Publications (1)

• Zaltzman JS, Lai V, Schulz MZ, Moon KH, Cherney DZ. A randomized cross-over comparison of short-term exposure of once-daily extended release tacrolimus and twice-daily tacrolimus on renal function in healthy volunteers. Transpl Int. 2014 Dec;27(12):1294-302. doi: 10.1111/tri.12435. Epub 2014 Sep 29.

  PMID: 25160518 DERIVED

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Associate Director, Medical Affairs

  Astellas Pharma Canada, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 7, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 8, 2012

Record last verified: 2012-11

Locations

CA (1)