Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily

Phase 3

Completed

Conditions: Renal Failure

Interventions: Drug: LCP-Tacro
Drug: Prograf

Registration Number: NCT00817206

Lead Sponsor: Veloxis Pharmaceuticals

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 326

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCP-Tacro	LCP-Tacro	LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
Prograf (tacrolimus)	Prograf	Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)

Primary Outcome Measures

Name	Time	Method
Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up.	12 months

Secondary Outcome Measures