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Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:
Mycophenolic Acid Pharmacokinetics and Pharmacogenomics - Impact on the Clinical Outcomes of Patients With Severe Lupus Nephritis

Clinical Trial Summary

This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12 hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. The MPA levels will be correlated with clinical parameters and outcomes. Pharmacogenomics studies will also be carried out and correlated with MPA exposure and clinical outcomes.

Clinical Trial Description

This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12 hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. The MPA levels will be correlated with clinical parameters and outcomes. For active patients, the MPA levels will be correlated with treatment response (CR or PR) and side effects. For patients in remission, the MPA levels will be correlated with drug tolerability and relapse. Pharmacogenomics studies will also be carried out and correlated with MPA exposure and clinical outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02453997
Study type Observational
Source The University of Hong Kong
Contact Desmond Yap, MD
Phone 85222553879
Email desmondy@hku.hk
Status Recruiting
Phase N/A
Start date October 2012
Completion date December 2019
View Details
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