Pharmacokinetic Interaction of Piperine with Tacrolimus and Mycophenolic Acid in the Renal Transplant Recipients.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Changes in Cmax (maximum plasma concentration)
研究概览
简要总结
This study evaluates how piperine affects the pharmacokinetics of tacrolimus and mycophenolic acid in kidney transplant patients. These patients often need high doses of immunosuppressants like tacrolimus and MMF due to variability in how their bodies absorb and process these drugs. Both drugs have narrow therapeutic ranges, and maintaining appropriate blood levels is critical to prevent rejection or toxicity. Piperine, a natural compound found in black pepper, is known to enhance the absorption of various drugs by inhibiting enzymes and transporters that reduce drug levels. This study aims to test if piperine can safely increase the blood levels of tacrolimus and MPA in transplant patients, potentially allowing lower doses to be used. Two dosing schedules of piperine are being studied, and outcomes like peak concentration, time to peak, area under the curve, and clearance will be compared before and after piperine use. The ultimate goal is to improve drug effectiveness and safety in renal transplant recipients through dose optimization using piperine as a bioenhancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult renal transplant patients after 1 week post transplantation period aged 18 to 65 years Those requiring more than 0.3 mg per kgs of tacrolimus Unable to attain therapeutic tacrolimus trough concentration in the post transplantation period Renal allograft function returned to CKD 1 or 2 Hepatic function within normal limits Hb more than 10 Willing to comply with the study procedures by providing written informed consent.
排除标准
- •Recipients of multi-organ transplantation Concurrent use of drugs altering tacrolimus pharmacokinetics other than prednisolone Patients have been started on ketoconazole or diltiazem due to non-attainment of desired trough concentration Active infections at enrolment or within 30 days prior to enrolment Acute transplant rejection episodes Ongoing diarrheal episodes Patients harbouring HIV and hepatitis B or C infection Suffering from any malignancy requiring recent surgery or chemotherapy or irradiation Patients who had received any investigational drug within past six months History of hypersensitivity to piperine or tacrolimus or MMF Pregnant women or nursing mothers or women of childbearing potential without an effective method of birth control.
结局指标
主要结局
Changes in Cmax (maximum plasma concentration)
时间窗: Baseline and 1 week post intervention administration
Changes in Tmax (time to reach Cmax)
时间窗: Baseline and 1 week post intervention administration
Changes in AUC 0-12 h (area under the concentration-time curve from 0 to 12 hours)
时间窗: Baseline and 1 week post intervention administration
次要结局
- Changes in Ka(Changes in Kel)
研究者
Smita Pattanaik
Post Graduate Institute of Medical Education and Research Chandigarh