Clinical Trial: Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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.

Detailed 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. 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.
Sponsor: The University of Hong Kong

Current Primary Outcome: AUC (0-12) [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Infection [ Time Frame: 24 months ]
  • Gastrointestinal disturbances [ Time Frame: 24 months ]
  • Complete or partial remission [ Time Frame: 24 months ]
  • Relapse [ Time Frame: 24 months ]


Original Secondary Outcome: Same as current

Information By: The University of Hong Kong

Dates:
Date Received: May 21, 2015
Date Started: October 2012
Date Completion:
Last Updated: December 2, 2015
Last Verified: December 2015