DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: extended release tacrolimus (Drug); cyclosporine A microemulsion (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Canada, Inc.

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Comparison of Effective Renal Plasma Flow response

Secondary outcome:

Comparison of Glomerular Filtration Rate response

Comparison of blood pressure response

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

Montreal, Quebec H3X 2H9, Canada
Additional Information

Link to Results on JAPIC - enter 140499 in the JapicCTI-RNo. field

Starting date: April 2008
Last updated: July 7, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017