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

NCT ID: NCT00818194

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-09-30

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A. tacrolimus first

Subjects receive extended release tacrolimus in first dosing interval then cross over to cyclosporine A for second dosing interval

Group Type: EXPERIMENTAL

extended release tacrolimus

Intervention Type: DRUG

oral

cyclosporine A microemulsion

Intervention Type: DRUG

oral

B. cyclosporine first

Subjects receive cyclosporine A in first dosing interval then cross over to extended release tacrolimus for second dosing interval

Group Type: EXPERIMENTAL

extended release tacrolimus

Intervention Type: DRUG

oral

cyclosporine A microemulsion

Intervention Type: DRUG

oral

Interventions

extended release tacrolimus

oral

Intervention Type: DRUG

cyclosporine A microemulsion

oral

Intervention Type: DRUG

Other Intervention Names

Advagraf®; FK506E; MR4; Neoral®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Canada, Inc.

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Canada, Inc.

Locations

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

FKC-012

Identifier Type: -

Identifier Source: org_study_id

Health Canada Control # 119562

Identifier Type: -

Identifier Source: secondary_id