Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
Primary Purpose
Renal Failure
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
LCP-Tacro
Prograf
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure focused on measuring kidney transplantation, renal transplantation, maintenance immunosuppression, tacrolimus, Prevention of acute allograft rejection
Eligibility Criteria
Inclusion Criteria:
- Men and women at least 18 years of age who are recipients of a kidney transplant between 3 months and 5 years before the screening date
- Patients taking oral Prograf® capsules twice daily, at least 2 mg total dose per day, as part of their maintenance immunosuppression therapy, with tacrolimus trough levels of 5 to 15 ng/mL
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before receiving study drug
Exclusion Criteria:
- Recipients of any transplanted organ other than kidney
- Recipients of a bone marrow transplant
- Patients with an eGFR (MDRD7) < 30 mL/min at Screening
- Patients with a spot protein:creatinine ratio > 0.5
- Patients with a WBC count ≤ 2.8 ´ 109/L unless the WBC count has been stable for at least 2 weeks and the absolute neutrophil count is > 1.0 ´ 109 /L
- Patients unable to swallow study medication
- Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent and who are unwilling or unable to comply with the study protocol requirements
- Pregnant or nursing women
- Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception
- Patients who were treated with any other investigational agent within 3 months before Screening
- Patients who have taken sirolimus or everolimus within 3 months before Screening
- Patients on concurrent immunosuppression with MMF (CellCept) or MPS delayed-release tablets (Myfortic) who have not been on stable doses for at least 4 weeks before Screening
- Patients withdrawn from corticosteroids less than 30 days before Screening
- Patients with an episode of acute rejection requiring antibody therapy within 3 months before Screening
- Patients treated for acute rejection within 30 days before Screening
- Patients who are hepatitis C virus (HCV) negative who have received an HCV positive (HCV RNA by polymerase chain reaction or HCV antibody) donor kidney
- Patients seropositive for human immunodeficiency virus
- Patients with a current malignancy or a history of malignancy (within the past 5 years), except basal or nonmetastatic squamous cell carcinoma of the skin that has been treated successfully
- Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
- Patients with severe diarrhea, vomiting, active peptic ulcer, or gastrointestinal disorder that may affect the absorption of tacrolimus
- Patients with any form of current substance abuse, psychiatric disorder, or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
Sites / Locations
- California Institute of Renal Research/ Sharp Memorial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LCP-Tacro
Prograf (tacrolimus)
Arm Description
LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Outcomes
Primary Outcome Measures
Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up.
Secondary Outcome Measures
Full Information
NCT ID
NCT00817206
First Posted
December 19, 2008
Last Updated
August 11, 2015
Sponsor
Veloxis Pharmaceuticals
Collaborators
PPD
1. Study Identification
Unique Protocol Identification Number
NCT00817206
Brief Title
Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
Official Title
Ph3, Open Label, Multi-Ctr, Pros, Rand Study -Efficacy and Safety, Conversion Prograf® Capsules BID to LCPTacro Tablets QD, for Prevent of Acute Allograft Rejection in Stable Kidney Transplant pt.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veloxis Pharmaceuticals
Collaborators
PPD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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, Horsholm, Denmark) once daily for the prevention of acute allograft rejection in stable adult make and female kidney transplant patients. Recipients of kidney transplant 3 months to 5 years before Screening and 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. There will be 11 study visits in the Treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
kidney transplantation, renal transplantation, maintenance immunosuppression, tacrolimus, Prevention of acute allograft rejection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LCP-Tacro
Arm Type
Experimental
Arm Description
LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
Arm Title
Prograf (tacrolimus)
Arm Type
Active Comparator
Arm Description
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Intervention Type
Drug
Intervention Name(s)
LCP-Tacro
Other Intervention Name(s)
tacrolimus, tacrolimus modified release
Intervention Description
LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.
Intervention Type
Drug
Intervention Name(s)
Prograf
Other Intervention Name(s)
tacrolimus
Intervention Description
Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.
Primary Outcome Measure Information:
Title
Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women at least 18 years of age who are recipients of a kidney transplant between 3 months and 5 years before the screening date
Patients taking oral Prograf® capsules twice daily, at least 2 mg total dose per day, as part of their maintenance immunosuppression therapy, with tacrolimus trough levels of 5 to 15 ng/mL
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before receiving study drug
Exclusion Criteria:
Recipients of any transplanted organ other than kidney
Recipients of a bone marrow transplant
Patients with an eGFR (MDRD7) < 30 mL/min at Screening
Patients with a spot protein:creatinine ratio > 0.5
Patients with a WBC count ≤ 2.8 ´ 109/L unless the WBC count has been stable for at least 2 weeks and the absolute neutrophil count is > 1.0 ´ 109 /L
Patients unable to swallow study medication
Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent and who are unwilling or unable to comply with the study protocol requirements
Pregnant or nursing women
Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception
Patients who were treated with any other investigational agent within 3 months before Screening
Patients who have taken sirolimus or everolimus within 3 months before Screening
Patients on concurrent immunosuppression with MMF (CellCept) or MPS delayed-release tablets (Myfortic) who have not been on stable doses for at least 4 weeks before Screening
Patients withdrawn from corticosteroids less than 30 days before Screening
Patients with an episode of acute rejection requiring antibody therapy within 3 months before Screening
Patients treated for acute rejection within 30 days before Screening
Patients who are hepatitis C virus (HCV) negative who have received an HCV positive (HCV RNA by polymerase chain reaction or HCV antibody) donor kidney
Patients seropositive for human immunodeficiency virus
Patients with a current malignancy or a history of malignancy (within the past 5 years), except basal or nonmetastatic squamous cell carcinoma of the skin that has been treated successfully
Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
Patients with severe diarrhea, vomiting, active peptic ulcer, or gastrointestinal disorder that may affect the absorption of tacrolimus
Patients with any form of current substance abuse, psychiatric disorder, or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Steinberg, M.D.
Organizational Affiliation
Claifornia Institute of Renal Research/Sharp Memorial
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Institute of Renal Research/ Sharp Memorial
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
We'll reach out to this number within 24 hrs