Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Evaluation of AUC(0-24) for Envarsus XR and IR-Tac
研究概览
简要总结
Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.
详细描述
This is open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of once daily dosing of LCP-Tacro tablets to tacrolimus capsules administered twice daily in stable African American kidney transplant patients.
Approximately 72 male and female African American renal transplant patients on table immunosuppression regimens will be randomly assigned in a 1:1 ratio to one of two sequences:
Sequence 1: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will continue on generic tacrolimus capsules on days 1-7 (24 hours PK profile on day 7) then patients are switched to LCP-Tacro tablets (at 15% lower dose of twice daily generic tacrolimus) on day 8.
Sequence 2: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will receive LCP-Tacro tablets (at 15% lower dose than generic tacrolimus twice daily formulation) on days 1-7 (24 hour PK profile on day 7) patients are switched back to twice daily generic tacrolimus treatment beginning on day 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Evidence of acute rejection episode within the past three months
- •Pt not Africa-American
- •Recipients of organ transplants other than kidney
- •Known to be HIV positive at transplant
- •Pt with recurrent focal segmental glomerulosclerosis (FSGS)
- •Pt with any severe medical condition (including infection) requiring acute or chronic treatment
- •Pt with a positive DSA
- •Pt with a positive BK virus results
- •GFR < 25 ml/min measured by MDRD4 as SOC within last 30 days
- •Patients with AST, ALT, total bilirubin > 2.5 x ULN or evidence of severe liver disease
- •Pt with WBC < to 2000/mm3 or ANC < to 1500 mm3 with PLT < 75,000/mm3 or HGB < 8 g/dl
- •Pt with mental or physical conditions or known non-adherence
- •Presence of intractable immunosuppressant complications of side effects resulting in dose adjustment of tacrolimus
- •Exposed to investigational therapy within 30 days prior to enrollment
- •No anticipated changes in the immunosuppressive regimen, other than those specified by the study protocol
- •Pt with severe diabetic gastroparesis or other severe GI disturbances
- •Pt who have underwent gastric banding or gastric bypass at any time pre or post-transplant
- •Pregnant or nursing (lactating) women, or planning to become pregnant
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC of method
研究组 & 干预措施
LCP-Tacro
Envarsus XR
干预措施: LCP-Tacro (Drug)
Tacrolimus - IR
Tacrolimus
干预措施: Tacrolimus -IR (Drug)
结局指标
主要结局
Evaluation of AUC(0-24) for Envarsus XR and IR-Tac
时间窗: Day 21
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Evaluation of C(Max) for Envarsus XR and IR-Tac
时间窗: Day 21
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Evaluation of C(Min) for Envarsus XR and IR-Tac
时间窗: Day 21
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
次要结局
未报告次要终点