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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 302

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 a stable dose of oral Prograf capsules twice daily, a least 2 mg total dose per day, as part of their maintenance immunosuppression therapy, with tacrolimus trough levels of 4 to 15 ng/mL. Patients must maintain tacrolimus trough levels in this range during the 7-day Run-in Period to be eligible for randomization (based on two consecutive trough level measurements at least 48 hours apart. )
A stable dose of Prograf is defined as a dose that has been unchanged for at least 30 days.

Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before receiving study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 white blood cell (WBC) count = 2.8 × 10^9/L unless the WBC count has been stable for at least 2 weeks and the absolute neutrophil count is > 1.0 × 10^9 /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

Patients who are committed to an institution by an official or judicial order

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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