Pharmacokinetic Cross-over Study to Evaluate the Influence of Pantoprazole on MPA Bioavailability Administered as Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Maintenance Renal Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dose-normalized AUC of Mycophenolic Acid
研究概览
简要总结
The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.
详细描述
It is a randomized open-label 4-sequence 4-period pharmacokinetic cross-over study. The objective of the pharmacokinetic study is to examine a drug-drug interaction of pantoprazole on the bioavailability mycophenolic acid administered as either mycophenolate mofetil (Cellcept(R) or mycophenolate Sodium; EC-MPS (Myfortic (R) in stable renal allograft recipients under maintenance immunosuppressive therapy (cyclosporine +/- low dose glucocorticoids).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients >18 years old
- •patients who are on stable immunosuppressive therapy for at least one month with ciclosporin, EC-MPS or MMF +/- corticosteroids
- •renal transplantation, at least 6 months prior study inclusion
- •suitable and willing to switch treatment according to the study plan
- •women of childbearing potential must have a negative serum pregnancy test before study start and effective contraception must be used (method with PEARL index <1%)
排除标准
- •patients with renal function <30ml/min (estimated by Cockcroft Gault formula)
- •patients who are not on stable treatment with enzyme inductors or enzyme inhibitors for <1 month before study entry
- •patients who take medication which is known for interfering with MPA absorption for <1 month before study entry
- •known anamnestic hypersensitivity to one of the investigational products or drugs with similar chemical structure and to other components of the investigational products, respectively
- •patients on treatment with clopidogrel
- •acute rejection < 1 month before study inclusion
- •patients who are HIV positive, hepatitis C virus (HCV) positive, HBsAg positive
- •patients with gastrointestinal disorders which could affect resorption
- •pregnancy and/or lactation
- •drug or alcohol abuse in patient's history
- •patients with history of psychological illness or condition, which might interfere with the ability to understand the requirements, consequences, possible outcome of the study and patients who are not willing to give valid informed consent
- •patients with insufficient co-operation with the clinical investigator (e.g. suspicion of non-compliance)
研究组 & 干预措施
Mycophenolate mofetil (C)
Mycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks.
干预措施: Mycophenolate mofetil (Drug)
Mycophenolate mofetil+Pantoprazole (C+P)
Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks.
干预措施: Pantoprazole (Drug)
Mycophenolate mofetil+Pantoprazole (C+P)
Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks.
干预措施: Mycophenolate mofetil (Drug)
Mycophenolate sodium (M)
Mycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks.
干预措施: Mycophenolate sodium (Drug)
Mycophenolate sodium+Pantoprazole (M+P)
Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks.
干预措施: Mycophenolate sodium (Drug)
Mycophenolate sodium+Pantoprazole (M+P)
Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks.
干预措施: Pantoprazole (Drug)
结局指标
主要结局
Dose-normalized AUC of Mycophenolic Acid
时间窗: Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for PK/PD analysis will be collected. On the next day new treatment starts. There are 4 study visits at the study center. Duration will be approximately 12hours
Bioavailability (12h AUC) of mycophenolic acid in renal transplant patients after administration of MMF+/-PAN and EC-MPS+/-PAN For evaluation of pharmacokinetic and pharmacodynamic parameters blood will be collected before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after drug intake.
次要结局
未报告次要终点
研究者
Klemens Budde
Professor Dr Klemens Budde
Charite University, Berlin, Germany