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Sponsors and Collaborators: |
LifeCycle Pharma A/S PPD |
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Information provided by: | LifeCycle Pharma A/S |
ClinicalTrials.gov Identifier: | NCT00817206 |
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy with LCP Tacro™ tablets (tacrolimus, LifeCycle Pharma A/S, Hoersholm, Denmark) once daily for the prevention of acute allograft rejection in stable adult kidney transplant patients. Patients on a stable dose of Prograf® will be randomly assigned to be converted from Prograf® twice daily to LCP Tacro™ once daily or to remain on maintenance therapy with Prograf® twice daily. Patients entering the study will be treated with assigned study drug and followed for one year for patient survival and the incidence of graft rejection or graft loss.
Condition | Intervention | Phase |
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Acute Allograft Rejection |
Drug: LCP-Tacro™ Tablets (tacrolimus) Drug: Prograf® capsules (tacrolimus) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Open-Label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion From Prograf® Capsules Twice Daily to LCP Tacro™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients |
Estimated Enrollment: | 302 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
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Drug: LCP-Tacro™ Tablets (tacrolimus)
Dosage is determined by monitoring trough levels
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2: Active Comparator
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
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Drug: Prograf® capsules (tacrolimus)
Dosage is determined by monitoring of trough levels
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rob Gordon, M.D. | 646 200-8516 | RGO@LCPharma.com |
Contact: Naseem Sofia | 646 200-8509 | NSO@LCPharma.com |
United States, California | |
California Institute of Renal Research/ Sharp Memorial | Recruiting |
San Diego, California, United States, 92123 |
Principal Investigator: | Steven Steinberg, M.D. | Claifornia Institute of Renal Research/Sharp Memorial |
Responsible Party: | LifeCycle Pharma A/S, Kogle Allé 4, 2970 Hørsholm, Denmark ( Karin Jexner Hamberg, M.D. Executive Vice President for R&D and CMO ) |
Study ID Numbers: | LCP-Tacro 3001 |
Study First Received: | December 19, 2008 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00817206 |
Health Authority: | United States: Food and Drug Administration |
kidney transplantation renal transplantation maintenance immunosuppression tacrolimus Prevention of acute allograft rejection |
Tacrolimus |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |