Investigating the Feasibility of Estimating Mycophenolic Acid from Saliva using High Performance Liquid Chromatography – Fluorescence Method for Determining Mycophenolate Exposure in Patients with Renal Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anticipated outcomes involve confirming the specificity and selectivity of the established High Performance Liquid Chromatography- fluorescence method for determining Mycophenolic Acid (MPA) concentrations in both saliva and plasma. The success of this method could position it as a reliable approach for Therapeutic Drug Monitoring (TDM) of MPA in diverse patient groups, irrespective of age.
研究概览
简要总结
We believe that our study will be able to validate a non-invasive method of Therapeutic Drug Monitoring for Mycophenolate Mofetil (MMF) using saliva samples and in developing an algorithm correlating salivary concentrations of MMF to that of blood concentrations of MMF. The study will be conducted in the Department of Pharmacology, PGIMER in collaboration with Department of Renal Transplantation and Surgery, PGIMER. The study will include 30 adult patients who have undergone renal transplantation ≥4 weeks prior and are prescribed MMF twice daily and have maintained a stable dosage for the past two weeks. Those willing to participate, and provide consent will be screened for inclusion in the study. Blood and saliva specimen will be collected prior to the administration of MMF, with subsequent samples obtained at specified intervals of 0.33, 1, 2, 4, 6, 8, and 12 hours following MMF administration. The samples will be further analyzed using High Performance Liquid Chromatography using Fluorescence detector. The exposure of Mycophenolic Acid (MPA) will be calculated using AUC (0-12 hour) and correlation between saliva and plasma MPA will be established using parametric or non-parametric statistical tests.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult stable renal transplantation studies and patients with normal albumin range.
排除标准
- •Patients with multi organ transplantation Pregnant or lactating women Patients with secondary infection or malignancy.
结局指标
主要结局
Anticipated outcomes involve confirming the specificity and selectivity of the established High Performance Liquid Chromatography- fluorescence method for determining Mycophenolic Acid (MPA) concentrations in both saliva and plasma. The success of this method could position it as a reliable approach for Therapeutic Drug Monitoring (TDM) of MPA in diverse patient groups, irrespective of age.
时间窗: Before drug administration, 20 mins after drug administration followed at 1hr, 2hr, 4 hr , 6 hr , 8 hr and 12 hr
次要结局
- correlation between plasma AUC and saliva AUC of MPA in Renal transplant patients(Before drug administration, 20 mins after drug administration followed at 1hr, 2hr, 4 hr , 6 hr , 8 hr and 12 hr)
研究者
Prof Smita Pattanaik
PGIMER