A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers
This study has been completed.
Sponsor:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Canada, Inc. )
ClinicalTrials.gov Identifier:
NCT01681134
First received: September 5, 2012
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Advagraf® Drug: Prograf® |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Effective Renal Plasma Flow (ERPF) [ Time Frame: up to Day 20 ] [ Designated as safety issue: No ]Estimated by aminohippurate sodium (PAH) clearance
Secondary Outcome Measures:
- Glomerular Filtration Rate (GFR) [ Time Frame: Pre-dose (Day -4), Day 10, Day 20 ] [ Designated as safety issue: No ]Estimated by sinistrin clearance
| Enrollment: | 19 |
| Study Start Date: | July 2012 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Advagraf followed by Prograf |
Drug: Advagraf®
oral
Other Name: tacrolimus XL, FK506E
Drug: Prograf®
oral
Other Name: tacrolimus, FK506
|
| Experimental: Prograf followed by Advagraf |
Drug: Advagraf®
oral
Other Name: tacrolimus XL, FK506E
Drug: Prograf®
oral
Other Name: tacrolimus, FK506
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681134
Locations
| Canada, Ontario | |
| INC Research | |
| Toronto, Ontario, Canada, M5V 2T3 | |
Sponsors and Collaborators
Astellas Pharma Canada, Inc.
Investigators
| Study Director: | Associate Director, Medical Affairs | Astellas Pharma Canada, Inc. |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc ( Astellas Pharma Canada, Inc. ) |
| ClinicalTrials.gov Identifier: | NCT01681134 History of Changes |
| Other Study ID Numbers: | FKC-016 |
| Study First Received: | September 5, 2012 |
| Last Updated: | November 6, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Astellas Pharma Inc:
|
tacrolimus Advagraf® Prograf® Glomerular Filtration Rate |
Effective Renal Plasma Flow Pharmacokinetics Pharmacodynamics |
Additional relevant MeSH terms:
|
Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013