Comparison of Extended Release Tacrolimus (Advagraf) and Cyclosporine A Microemulsion on Renal Function in Healthy Volunteers

July 7, 2014 updated by: Astellas Pharma Inc

A Comparison of Effects of Short-term Low Dose Exposure of Advagraf® and Neoral® Microemulsion Cyclosporine A on Renal Perfusion and Function in Healthy Volunteers

The purpose of this study is to compare the effects of steady state tacrolimus vs. cyclosporine on renal pharmacodynamics in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study seeks to evaluate the renal physiological responses of short-term maintenance level doses of CNIs in healthy volunteers to determine if daily perturbations in renal physiology exist, and if confirmed, whether they differ between CNIs and thus may contribute by different mechanisms to the progression of CAN.

Study Type

Interventional

Enrollment (Actual)

18

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
    • Quebec
      • Montreal, Quebec, Canada, H3X 2H9

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
  • healthy with no history or current clinical findings of infection or disease of the following nature: cerebrovascular, neurologic, cardiovascular, endocrine, pulmonary, immunologic, metabolic, hematologic, diabetes mellitus, glucose intolerance, gout
  • non-smoker and willing to abstain from alcohol consumption during the study
  • agrees to use appropriate contraception during the study period until 3 months after the final study exam.

Exclusion Criteria:

  • history of significant alcohol abuse or drug abuse within 1 year prior to the screening visit
  • regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week)
  • use of soft drugs (marijuana) within 3 months prior to the screening visit or hard drugs (cocaine, PCP, crack) within 1 year prior to the screening visit Hepatitis B or C, HIV, history of cancer (excluding excised squamous or basal cell carcinoma)
  • positive tuberculin skin test or prior TB infection
  • known history of serious head injuries, seizures or any eating disorder
  • received an investigational drug within 30 days prior to the first study drug administration
  • known hypersensitivity/allergy to tacrolimus, cyclosporine, iothalamate iodine, para-aminohippuric acid, antibiotics or antifungals
  • Body mass index (BMI) <19 or >27
  • clinically significant history of psychiatric disease or a significant disability that prevents understanding or adherence to protocol
  • renal dysfunction, serum creatinine or urine microalbumin above the normal age and gender-adjusted reference range of the local lab
  • clinically significant abnormal liver function test indicative of impaired hepatic function
  • received medications/herbal preparations that may affect the metabolism of tacrolimus or cyclosporine A within 1 month of the first study drug administration
  • received any other prescription medication within 14 days prior to the first study drug administration or any over-the-counter product within 7 days prior to the first study drug administration, except for topical products without systemic absorption
  • current GI condition known to affect GI motility and/or absorption
  • donation of plasma (500 mL) within 7 days prior to the first study drug administration or donation/ loss of whole blood as follows: 50 mL to 499 mL within 30 days or more than 499 mL within 56 days prior to the first study drug administration
  • clinically significant surgery within 4 weeks prior to the first study drug administration
  • administration of steroids by injection within 12 weeks prior to the first study drug administration
  • administration of any live vaccine within 7 days prior to the first study drug administration
  • travel in areas where TB is endemic within 8 weeks prior to the TB skin test performed at the screening visit
  • hemoglobin <140 g/L

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A. tacrolimus first
Subjects receive extended release tacrolimus in first dosing interval then cross over to cyclosporine A for second dosing interval
Drug: extended release tacrolimus
oral
Other Names:
  • FK506E
  • MR4
  • Advagraf®
Drug: cyclosporine A microemulsion
oral
Other Names:
  • Neoral®
EXPERIMENTAL: B. cyclosporine first
Subjects receive cyclosporine A in first dosing interval then cross over to extended release tacrolimus for second dosing interval
Drug: extended release tacrolimus
oral
Other Names:
  • FK506E
  • MR4
  • Advagraf®
Drug: cyclosporine A microemulsion
oral
Other Names:
  • Neoral®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of Effective Renal Plasma Flow response
Time Frame: Baseline and Day 10 of each dosing interval
Baseline and Day 10 of each dosing interval

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of Glomerular Filtration Rate response
Time Frame: Baseline and Day 10 of each dosing interval
Baseline and Day 10 of each dosing interval
Comparison of blood pressure response
Time Frame: Baseline and Day 10 of each dosing interval
Baseline and Day 10 of each dosing interval

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Collaborators

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.

Helpful Links

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

April 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (ESTIMATE)

January 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKC-012
  • Health Canada Control # 119562

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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