Status:
COMPLETED
Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
Lead Sponsor:
Veloxis Pharmaceuticals
Collaborating Sponsors:
PPD Development, LP
Conditions:
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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- Patients withdrawn from corticosteroids less than 30 days before Screening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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00817206
Start Date
December 1 2008
End Date
February 1 2011
Last Update
September 10 2015
Active Locations (1)
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1
California Institute of Renal Research/ Sharp Memorial
San Diego, California, United States, 92123