Lupus NephritisNCT02453997
Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis
An observational study of Lupus Nephritis, run by The University of Hong Kong at 2 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus Nephritis
- How many people
- 88 participants
- Where
- 2 sitesHong Kong
- Study dates
- Oct 2012to 17 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lupus Nephritis patients (both active or remission)
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital, Hong Kong
Hong Kong
United Christian Hospital
Hong Kong
About this study
Official title: Mycophenolic Acid Pharmacokinetics and Pharmacogenomics - Impact on the Clinical Outcomes of Patients With Severe Lupus Nephritis
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.
Read the 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
- Lupus Nephritis
- Keywords
- lupus nephritis, mycophenolic acid, pharmacokinetics, pharmacogenomics
- Medical subject headings
- Lupus Nephritis
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (0-12)
Measured: 24 months
Secondary outcomes (4)
Infection
Measured: 24 months
Gastrointestinal disturbances
Measured: 24 months
Complete or partial remission
Measured: 24 months
Relapse
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startOct 2012
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- United Christian Hospital
- Responsible party
- Principal investigator, Dr. Desmond Yat-Hin Yap, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453997
- Sponsor's protocol ID
- UW12-462
- Status last verified
- Dec 2024
- First submitted
- 21 May 2015
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycophenolic Acid Pharmacokinetics and Pharmacogenomics - Impact on the Clinical Outcomes of Patients With Severe Lupus Nephritis
- ClinicalTrials.gov ID
- NCT02453997
- Acronym / sponsor ID
- UW12-462
- Conditions
- Lupus Nephritis
- Keywords
- lupus nephritis, mycophenolic acid, pharmacokinetics, pharmacogenomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- United Christian Hospital
- Study start
- Oct 2012
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lupus Nephritis patients (both active or remission)
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AUC (0-12)
Time frame: 24 months
4 secondary outcomes
Infection
Time frame: 24 months
Gastrointestinal disturbances
Time frame: 24 months
Complete or partial remission
Time frame: 24 months
Relapse
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (0-12) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.