Lupus NephritisPhase 4NCT01203709
Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis
A Phase 4 study testing low dose combination of MMF and Tac in people with Lupus Nephritis, run by Tuen Mun Hospital at 1 site in China.
Trial summary
A trial of combination of two drugs for the treatment of refractory lupus nephritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- low dose combination of MMF and Tac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Feb 2013
- Phase
- Phase 4
- 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
Who may be able to join
- Active nephritis documented by renal biopsy within 24 months of entry;
- Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
- Serum creatinine (Scr) less than 200umol/L.
Who cannot join
- Previous intolerance to either MMF/Tac;
- Scr >200umol/L;
- Informed consent unavailable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study
A trial of combination of two drugs for the treatment of refractory lupus nephritis.
Read the detailed description
Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study
- Conditions
- Lupus Nephritis
- Being tested
- low dose combination of MMF and Tac
- Keywords
- lupus, nephritis, glomerulonephritis, nephropathy, refractory
- Medical subject headings
- Lupus Nephritis, Nephritis, Glomerulonephritis, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose combination of MMF and TacDrug
Also called Cellcept and Prograf
mycophenolate mofetil 500mg BID + tacrolimus 2mg BID
| Study group | Role | What they receive |
|---|---|---|
| Combination treatment | Experimental | treatment arm Receives: Drug: low dose combination of MMF and Tac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate
Measured: 12 months
Secondary outcomes (1)
Adverse events
adverse events experienced by patients as a measure of tolerability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionFeb 2013
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chi Chiu Mok, Tuen Mun Hospital
- Investigators
- CC Mok, MD, FRCP, Principal investigator, Tuen Mun Hospital, Hong Kong China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203709
- Sponsor's protocol ID
- NTWC/CREC/837/10
- Status last verified
- Mar 2014
- First submitted
- 15 Sep 2010
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study
- ClinicalTrials.gov ID
- NCT01203709
- Acronym / sponsor ID
- NTWC/CREC/837/10
- Conditions
- Lupus Nephritis
- Keywords
- lupus, nephritis, glomerulonephritis, nephropathy, refractory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Sep 2010 (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.
A trial of combination of two drugs for the treatment of refractory lupus nephritis.
Detailed description
Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination treatment | Experimental | Drug: low dose combination of MMF and Tactreatment arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active nephritis documented by renal biopsy within 24 months of entry;
- Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
- Serum creatinine (Scr) less than 200umol/L.
Key exclusion criteria (3 listed)
- Previous intolerance to either MMF/Tac;
- Scr >200umol/L;
- Informed consent unavailable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose combination of MMF and TacAlso: Cellcept and Prografmycophenolate mofetil 500mg BID + tacrolimus 2mg BID | Drug | Combination treatment |
Primary outcome
Clinical remission rate
Time frame: 12 months
1 secondary outcome
Adverse events
Time frame: 12 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 4 Mar 2014.
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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.
CC Mok, MD, FRCP principal investigator
Tuen Mun Hospital, Hong Kong China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low dose combination of MMF and Tac in people with Lupus Nephritis, run by Tuen Mun Hospital at 1 site in China.
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 3 inclusion and 3 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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical remission rate (time frame: 12 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 4 Mar 2014.