A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00282243
First received: January 24, 2006
Last updated: November 10, 2011
Last verified: November 2011
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Purpose
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Transplantation |
Drug: tacrolimus modified release (MR) Drug: tacrolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase 2, Open-Label, Multi-Center Study to Assess the Pharmacokinetics, Long-term Safety and Tolerability of Tacrolimus in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppression Regimen to a Modified Release (MR) Tacrolimus Based Immunosuppression Regimen |
Resource links provided by NLM:
MedlinePlus related topics:
Liver Transplantation
Drug Information available for:
Tacrolimus
U.S. FDA Resources
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Pharmacokinetics [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Long-term safety and tolerability [ Time Frame: 8 weeks treatment then extension treatment period until commercially available or notified by Astellas Pharma Inc. ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | February 2003 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: tacrolimus modified release (MR)
Oral
Other Name: Advagraf, FK506E-MR, MR4, FKMR
Drug: tacrolimus
Oral
Other Name: Prograf, FK506
|
Detailed Description:
A 1 arm study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is currently receiving Prograf ® based immunosuppressive therapy for liver transplantation.
- Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable
Exclusion Criteria:
- Patient has previously received an organ transplant other than a liver
- Patient is currently receiving sirolimus immunosuppression therapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282243
Locations
| United States, California | |
| Palo Alto, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States, 80262 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Texas | |
| Dallas, Texas, United States, 75246 | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Central Contact | Astellas Pharma US, Inc. |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00282243 History of Changes |
| Other Study ID Numbers: | 02-0-152 |
| Study First Received: | January 24, 2006 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Pharmacokinetics Therapy Immunosuppression Drugs, Investigational Adult |
Additional relevant MeSH terms:
|
Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013