Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis
1 other identifier
observational
88
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2012
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 21, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2019
CompletedDecember 12, 2024
December 1, 2024
6.5 years
May 21, 2015
December 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUC (0-12)
24 months
Secondary Outcomes (4)
Infection
24 months
Gastrointestinal disturbances
24 months
Complete or partial remission
24 months
Relapse
24 months
Eligibility Criteria
Lupus Nephritis patients (both active or remission)
You may qualify if:
- Patients with recent active LN (biopsy-proven Class III/IV+/-V LN according to the ISN/RPS 2003 classifications within 3 months, with proteinuria \>0.5 g/day and/or active urinary sediments) who receive corticosteroids and MMF (1g bd for 6 months) as induction treatment.
- LN patients in remission (defined as proteinuria \<0.5 g/day with inactive urinary sediment, prednisolone \<10 mg/day) and on stable MMF maintenance (dose unchanged within the previous 3 months).
You may not qualify if:
- Patients who receive enteric-coated mycophenolic acid (myfortic).
- Patients who receive concomitant calcineurin inhibitors (e.g. cyclosporine or tacrolimus) other than corticosteroids and MMF.
- Patients who receive concomitant medications which affect the MPA pharmacokinetics such as cholestyramine, acyclovir, and rifampicin.
- Patients who are pregnant or lactating.
- Patients with gastric emptying disorders
- Patients with hepatic or biliary diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- United Christian Hospitalcollaborator
Study Sites (2)
Queen Mary Hospital, Hong Kong
Hong Kong, Hong Kong
United Christian Hospital
Hong Kong, Hong Kong
Biospecimen
EDTA blood samples for pharmacogenomics analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
May 21, 2015
First Posted
May 27, 2015
Study Start
October 1, 2012
Primary Completion
April 17, 2019
Study Completion
April 17, 2019
Last Updated
December 12, 2024
Record last verified: 2024-12