HealthyPhase 1NCT01681134
A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers
A Phase 1 study testing Advagraf® and Prograf® in people with Healthy, run by Astellas Pharma Canada, Inc. at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys. 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?
- Advagraf® and Prograf®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Oct 2012
- 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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Effects of Short-Term Steady State Low Dose Exposure of Extended Release (Advagraf®) and Immediate Release (Prograf®) Formulations of Tacrolimus on Renal Perfusion and Function in Healthy Male Volunteers
The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.
Read the detailed description
This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10 days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the monitoring of drug levels in blood.
- Conditions
- Healthy
- Being tested
- Advagraf®, Prograf®
- Keywords
- tacrolimus, Advagraf®, Prograf®, Glomerular Filtration Rate, Effective Renal Plasma Flow, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advagraf®Drug
Also called tacrolimus XL, FK506E
oral
Prograf®Drug
Also called tacrolimus, FK506
oral
| Study group | Role | What they receive |
|---|---|---|
| Advagraf followed by Prograf | Experimental | Not described Receives: Drug: Advagraf®; Drug: Prograf® |
| Prograf followed by Advagraf | Experimental | Not described Receives: Drug: Advagraf®; Drug: Prograf® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Renal Plasma Flow (ERPF)
Estimated by aminohippurate sodium (PAH) clearance
Measured: up to Day 20
Secondary outcomes (1)
Glomerular Filtration Rate (GFR)
Estimated by sinistrin clearance
Measured: Pre-dose (Day -4), Day 10, Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Canada, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Director, Medical Affairs, Study director, Astellas Pharma Canada, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681134
- Sponsor's protocol ID
- FKC-016
- Status last verified
- Nov 2012
- First submitted
- 5 Sep 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25160518
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Effects of Short-Term Steady State Low Dose Exposure of Extended Release (Advagraf®) and Immediate Release (Prograf®) Formulations of Tacrolimus on Renal Perfusion and Function in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01681134
- Acronym / sponsor ID
- FKC-016
- Conditions
- Healthy
- Keywords
- tacrolimus, Advagraf®, Prograf®, Glomerular Filtration Rate, Effective Renal Plasma Flow, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Astellas Pharma Canada, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Sep 2012 (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 the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.
Detailed description
This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10 days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the monitoring of drug levels in blood.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advagraf followed by Prograf | Experimental | Drug: Advagraf®, Drug: Prograf® |
| Prograf followed by Advagraf | Experimental | Drug: Advagraf®, Drug: Prograf® |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Advagraf®Also: tacrolimus XL, FK506Eoral | Drug | Advagraf followed by Prograf, Prograf followed by Advagraf |
| Prograf®Also: tacrolimus, FK506oral | Drug | Advagraf followed by Prograf, Prograf followed by Advagraf |
Primary outcome
Effective Renal Plasma Flow (ERPF)
Time frame: up to Day 20
Estimated by aminohippurate sodium (PAH) clearance
1 secondary outcome
Glomerular Filtration Rate (GFR)
Time frame: Pre-dose (Day -4), Day 10, Day 20
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 8 Nov 2012.
- Derived from this study: PubMed 25160518Zaltzman 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.
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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.
Associate Director, Medical Affairs 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 Advagraf® and Prograf® in people with Healthy, run by Astellas Pharma Canada, 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 6 inclusion and 10 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 8 Nov 2012. 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?
Effective Renal Plasma Flow (ERPF) (time frame: up to Day 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681134, which also lists 1 linked publication.
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 8 Nov 2012.