HealthyPhase 1NCT00818194
Comparison of Extended Release Tacrolimus (Advagraf) and Cyclosporine A Microemulsion on Renal Function in Healthy Volunteers
A Phase 1 study testing extended release tacrolimus and cyclosporine A microemulsion in people with Healthy, run by Astellas Pharma Inc at 1 site in Canada.
Trial summary
The purpose of this study is to compare the effects of steady state tacrolimus vs. cyclosporine on renal pharmacodynamics in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- extended release tacrolimus and cyclosporine A microemulsion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to compare the effects of steady state tacrolimus vs. cyclosporine on renal pharmacodynamics in healthy volunteers.
Read the 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
- Being tested
- extended release tacrolimus, cyclosporine A microemulsion
- Keywords
- Tacrolimus, cyclosporine A, renal plasma flow, glomerular filtration rate, human, pharmacodynamics, pharmacokinetics, Pharmacodynamics of tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended release tacrolimusDrug
Also called Advagraf®, FK506E, MR4
oral
cyclosporine A microemulsionDrug
Also called Neoral®
oral
| Study group | Role | What they receive |
|---|---|---|
| A. tacrolimus first | Experimental | Subjects receive extended release tacrolimus in first dosing interval then cross over to cyclosporine A for second dosing interval Receives: Drug: extended release tacrolimus; Drug: cyclosporine A microemulsion |
| B. cyclosporine first | Experimental | Subjects receive cyclosporine A in first dosing interval then cross over to extended release tacrolimus for second dosing interval Receives: Drug: extended release tacrolimus; Drug: cyclosporine A microemulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Effective Renal Plasma Flow response
Measured: Baseline and Day 10 of each dosing interval
Secondary outcomes (2)
Comparison of Glomerular Filtration Rate response
Measured: Baseline and Day 10 of each dosing interval
Comparison of blood pressure response
Measured: Baseline and Day 10 of each dosing interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Canada, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818194
- Sponsor's protocol ID
- FKC-012
- Other IDs
- Health Canada Control # 119562
- Status last verified
- Jul 2014
- First submitted
- 6 Jan 2009
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00818194
- Acronym / sponsor ID
- FKC-012
- Conditions
- Healthy
- Keywords
- Tacrolimus, cyclosporine A, renal plasma flow, glomerular filtration rate, human, pharmacodynamics, pharmacokinetics, Pharmacodynamics of tacrolimus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. tacrolimus first | Experimental | Drug: extended release tacrolimus, Drug: cyclosporine A microemulsionSubjects receive extended release tacrolimus in first dosing interval then cross over to cyclosporine A for second dosing interval |
| B. cyclosporine first | Experimental | Drug: extended release tacrolimus, Drug: cyclosporine A microemulsionSubjects receive cyclosporine A in first dosing interval then cross over to extended release tacrolimus for second dosing interval |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended release tacrolimusAlso: Advagraf®, FK506E, MR4oral | Drug | A. tacrolimus first, B. cyclosporine first |
| cyclosporine A microemulsionAlso: Neoral®oral | Drug | A. tacrolimus first, B. cyclosporine first |
Primary outcome
Comparison of Effective Renal Plasma Flow response
Time frame: Baseline and Day 10 of each dosing interval
2 secondary outcomes
Comparison of Glomerular Filtration Rate response
Time frame: Baseline and Day 10 of each dosing interval
Comparison of blood pressure response
Time frame: Baseline and Day 10 of each dosing interval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study director
Astellas Pharma Canada, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing extended release tacrolimus and cyclosporine A microemulsion in people with Healthy, run by Astellas Pharma Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Effective Renal Plasma Flow response (time frame: Baseline and Day 10 of each dosing interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.