A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00282568
First received: January 25, 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 kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney 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, Safety and Tolerability of Tacrolimus in Stable Kidney 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:
Kidney Transplantation
Drug Information available for:
Tacrolimus
U.S. FDA Resources
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Determine and compare the pharmacokinetics [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the long-term safety and tolerability [ Time Frame: Until commercially available or notification by Astellas ] [ Designated as safety issue: No ]
| Enrollment: | 68 |
| Study Start Date: | August 2002 |
| 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, FKMR, MR4
Drug: tacrolimus
Oral
Other Name: Prograf, FK506
|
Detailed Description:
This is a Phase II open-label, multi-center conversion study in stable, adult kidney transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney 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 kidney 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 kidney
- Patient is currently receiving sirolimus immunosuppression therapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282568
Locations
| United States, California | |
| San Diego, California, United States | |
| United States, Florida | |
| Miami, Florida, United States, 33136 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97239 | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M5C 2T2 | |
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: | NCT00282568 History of Changes |
| Other Study ID Numbers: | 02-0-131 |
| Study First Received: | January 25, 2006 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
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 May 23, 2013