A Phase II, Open-Label, Multi-Center Prospective, Conversion Study in Stable Kidney Transplant Patients to Compare the Pharmacokinetics of LCP-Tacro Tablets Once-A-Day to Prograf® Capsules Twice-A-Day
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluation of Steady State Tacrolimus Trough Levels (C24).
研究概览
简要总结
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
详细描述
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
Stable kidney transplant patients who fulfill all I/E criteria will be enrolled and kept on Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for Prograf, all patients will be converted to once daily LCP-Tacro for 7 days with no dose changes allowed. On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day 22 patients will be converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days ending with a safety assessment on day 53.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18-65 years of age who are recipients of a renal transplant at least 6 months prior to enrollment
- •Patients on oral Prograf therapy as part of their maintenance immunosuppression therapy, with stable doses and trough levels of tacrolimus of 7-12 ng/mL for at least two weeks prior to enrollment.
- •Patients maintained on concurrent immunosuppression with mycophenolate mofetil (MMF, CellCept) or mycophenolic acid delayed-release tablets (Myfortic), with stable doses for at least two weeks prior to enrollment
- •Patients with serum creatinine < 2.0mg/dL prior to enrollment
- •Able to swallow study medication
- •Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study
- •Women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication
- •Patients who successfully pass a drug screen
排除标准
- •Recipients of any transplanted organ other than a kidney
- •White blood cell count < 2.8 x 10^9 /L
- •Patients who are receiving a total dose of Prograf for 24 hours < 3mg
- •Patients unable or unwilling to provide informed consent
- •Pregnant or nursing women
- •Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception
- •Administration of other investigational agent in the three months prior to enrollment
- •Patient receiving any drug interfering with tacrolimus metabolism
- •Patients who have taken sirolimus within the past three months prior to screening
- •Patient with an episode of acute cellular requiring antibody therapy within the 6 months prior to enrollment
- •Patient treated for acute cellular rejection within the 30 days prior to enrollment
- •Patient who is HCV negative and has received an HCV positive (HCV RNA by PCR or HCV antibody) donor kidney
- •Patient has a current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully
- •Patient has uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
- •Patient has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- •Patient will require therapy with any immunosuppressive agent other than those prescribed in the study
- •Patient has a known hypersensitivity to corticosteroids, mycophenolate mofetil, mycophenolic acid or tacrolimus
- •Patient has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator
研究组 & 干预措施
LCP-Tacro (tacrolimus)
Experimental: LCP Tacro; investigational product LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
干预措施: LCP Tacro (tacrolimus) (Drug)
LCP-Tacro (tacrolimus)
Experimental: LCP Tacro; investigational product LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
干预措施: Prograf (Drug)
结局指标
主要结局
Evaluation of Steady State Tacrolimus Trough Levels (C24).
时间窗: 7 days
Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
时间窗: 21 days
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).
Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).
时间窗: 21 days
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.
次要结局
- Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.(21 days)
- Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.(21 days)
- Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.(7 days)
- Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.(7 days)
- Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.(21 days)
- Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.(7 days)
- Safety Evaluation(52 days)