LCP-Tacro tablets will be investigated for immunosuppression for the prevention of acute allograft rejection in adult renal transplant patients. MedDRA version: 9.1 Level: LLT Classification code 10048870 Term: Prophylaxis against transplant rejection
Conditions
Interventions
Product Name: LCP-Tacro 0.5 mg tablets
Product Code: LCP-Tacro 0.5 mg tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TACROLIMUS
CAS Number: 104987113
Current Sponsor code: FK-506
FR-900506
Other descriptive name: Prograf
Fujimycin
L 679934
MLD 987
Tacrolimus
Tsukubaenolide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.510-
Product Name: LCP-Tacro 1 mg tablets
Product Code: LCP-Tacro 1 mg tablets
Pharmaceutical Form
Tsukubaenolide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.02-
Product Name: LCP-Tacro 2 mg tablets
Product Code: LCP-Tacro 2 mg tablets
Pharmaceutical Form:
Sponsors
LifeCycle Pharma A/S
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria: Recipients of any transplanted organ other than kidney Recipients of a bone marrow transplant Patients with an eGFR (MDRD7) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: To evaluate the efficacy and safety of LCP-Tacro tablets administered once daily when used to replace Prograf capsules administered twice daily for maintenance immunosuppression for prevention of acute allograft rejection in stable adult renal transplant patients.;Primary end point(s): Primary efficacy endpoint: A composite primary endpoint for noninferiority will be used for efficacy failure at 12 months after randomization and includes any patient experiencing any of the following within 12 months (by Day 360) after random assignment to treatment: death, graft failure (return to dialysis for > 30 days, allograft nephrectomy, or retransplantation), biopsy-proven acute rejection (BPAR, Banff grade = 1A) or lost to follow-up. The primary efficacy endpoint analysis will be performed using the modified intent to treat (mITT) analysis set consisting of all randomly assigned patients who receive at least one dose of study drug. Primary safety endpoint: All safety analyses will be performed using the mITT analysis set consisting of all randomly assigned patients who receive at least one dose of either study drug. The primary safety assessment will be the differences between treatment groups at Month 12 (Day 360) with respect to the incidence of adverse events (AEs) and the incidence of predefined potentially clinically significant laboratory measures including: fasting plasma glucose = 200 mg/dL; platelet count < 100 × 10^9 cells/L; white blood cell (WBC) count < 2.0 × 10^9 cells/L; aminotransaminases = 100 U/L; total cholesterol = 300 mg/dL; low density lipoprotein (LDL) cholesterol = 200 mg/dL; triglycerides = 500 mg/dL; and estimated glomerular filtration rate (eGFR) < 30 mL/min based on the Modification of Diet in Renal Disease 7 (MDRD7) equation. | — |
Countries
France, Germany, Spain, United Kingdom
Outcome results
None listed