Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating an Intensified Enteric-coated Mycophenolate Sodium (EC-MPS) Dosing Regimen in Comparison to a Standard Dosing Regimen of EC-MPS in Combination With Cyclosporin Microemulsion and Corticosteroids in de Novo Renal Transplant Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L
研究概览
简要总结
This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg*h/L compared to a standard dosing regimen of EC-MPS. Additionally, this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
研究组 & 干预措施
Intensified Mycophenolate sodium
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 180 days.
干预措施: Enteric-coated mycophenolate sodium (EC-MPS) (Drug)
Standard Mycophenolate sodium
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 6 months.
干预措施: Enteric-coated mycophenolate sodium (EC-MPS) (Drug)
结局指标
主要结局
Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L
时间窗: Assessed on day 3, 10, 21, 42, 56 and 84
Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.
Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment
时间窗: 6 months
Median time to first occurrence of treatment failure was not reached in this study.
Number of Participants With Any Treatment Failure
时间窗: 6 months
Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.
次要结局
- Number of Participants With Single Treatment Failures(6 months)
- Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180(6 months)
- Time to "Event" for the Composite Endpoint as Well as All Individual Components of That Endpoint "Treatment Failure" Including Clinical Rejections(6 months)
- Renal Function as Measured by Serum Creatinine(6 months)
- Renal Function as Measured by Glomerular Filtration Rate (GFR)(6 months)