Trials / Completed
CompletedNCT02453997
Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis
Mycophenolic Acid Pharmacokinetics and Pharmacogenomics - Impact on the Clinical Outcomes of Patients With Severe Lupus Nephritis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 88 (actual)
- Sponsor
- The University of Hong Kong · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2019-04-17
- Completion
- 2019-04-17
- First posted
- 2015-05-27
- Last updated
- 2024-12-12
Locations
2 sites across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT02453997. Inclusion in this directory is not an endorsement.