Pharmacokinetics, pharmacodynamics and efficacy of enteric-coated mycophenolate sodium in the treatment of relapse or resistant proliferative lupus nephritis
หัวหน้าโครงการ
:
ปาจรีย์ จริยวิลาศกุล (ลิลิตการตกุล)
ทีมวิจัย
:
ปาจรีย์ จริยวิลาศกุล (ลิลิตการตกุล)
หัวหน้าโครงการ
ยิ่งยศ อวิหิงสานนท์
นักวิจัยที่ปรึกษา
วันที่เริ่มโครงการ
:
2 ก.ค. 2555
วัตถุประสงค์
:
In a group of Thai patients with relapse or resistance proliferative LN, this study aims to assess:-
Primary objectives: pharmacokinetics and pharmacodynamics properties of EC-MPS as:
1. The changes of MPA-AUC0-12hr, Cmax, Tmax at 2, 8, 16 and 24 weeks after EC-MPS administration.
2. The relationship between MPA-AUC0-12hr, Cmax, Tmax at 2, 8, 16 and 24 weeks and clinical efficacy (according to American College of Rheumatology Response Criteria at 24 week after EC-MPS administration.
3. The changes of levels of IMDPH mRNA expression at 2, 8, 16 and 24 weeks after EC-MPS administration.
4. The relationship between levels of IMDPH mRNA expression at 2, 8, 16 and 24 weeks and clinical efficacy (according to American College of Rheumatology Response Criteria) at 24 week after EC-MPS administration.
Secondary objectives:
1. The inter-relationship between MPA-AUC0-12hr and levels of IMDPH mRNA expression at 2, 8, 16 and 24 weeks after EC-MPS administration.
2. The rate of adverse events occurred with EC-MPS.
3. The effect of EC-MPS on endothelial function at 2, 8, 16 and 24 weeks after EC-MPS administration.
Clinical response criteria according to the American College of Rheumatology Response Criteria
1. A complete response was defined as normal or ?25% decline of MDRD-GFR from baseline and a UPCR of <0.2 and inactive urinary sediment (urine white blood cells and red blood cells <5 cells per high-power-field)
2. A partial response was defined as normal or ?25% decline of MDRD-GFR from baseline and at least 50% reduction of proteinuria, with a level ranged between 0.2 to 2.0 g/day.
3. The participants who did not meet the above criteria were determined as non-responders.
