Lupus NephritisPhase 4NCT03920059
Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis
A Phase 4 study testing Mycophenolate Mofetil in people with Lupus Nephritis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteThailand
- Study dates
- 20 Aug 2019to 30 Jan 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 year
- Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE
- Active lupus nephritis (both new and flare patients can be included) defined as:
- Within 16 weeks of randomization, had Biopsy-proven ISN class III or IV [exclude III(c), IV-S(c) and IV-G(c). Patients are permitted to have co-existing class V and
- At screening day, has urine protein creatinine ratio (UPCR) or 24-hour urinary protein ≥ 1.0 g/g or g/day
Who cannot join
- Pregnancy or breast feeding
- Child-bearing age women who refuse to use effective birth-control
- Poor compliance
- Estimated-GFR < 20 mL/min/1.73 m2
- Crescentic glomeruli more than 30 percent
- Severe extra-renal involvement of SLE
Show all 21Show fewer
- History of severe allergic reactions or adverse effects to MMF
- Uncontrolled concomitant disease
- Known active, clinically significant infection of any kind
- History of serious recurrent or chronic infection
- History of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured)
- Concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time in the 52 weeks prior to screening
- Treatment with more than 1 g cyclophosphamide within the past 24 weeks
- Receipt more than 3 g of IV pulse methylprednisolone within the past 12 weeks
- Receipt prednisolone more than 30 mg/day for longer than 30 days within the past 12 weeks
- Treatment with MMF at ≥ 1.5 g/day for over 4 weeks within the past 12 weeks
- On treatment with Tacrolimus or Cyclosporine on the day of screening
- Treatment with any biologic B-cell depleting therapy (e.g. anti CD-20, anti CD 22) within 52 weeks
- Receiving concomitant medication interfering PK of MPA
- Cholestyramine
- Rifampin
Trial locations and contacts
1 site in 1 country.
Thailand1 site
King Chulalongkorn Memorial Hospital
Bangkok, Please Select, 10330
About this study
Official title: A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis
A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.
- Conditions
- Lupus Nephritis
- Being tested
- Mycophenolate Mofetil
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description Each capsule contains Mycophenolate mofetil 250 mg. Presentation / Packing Cap 250 mg (white to off white powder, light blue/peach hard gelatin, imprinting with "MMF" on cap and "250" on body) x 10 x 10's.
Storage Store below 30 degree Celcius.
| Study group | Role | What they receive |
|---|---|---|
| FD arm | Placebo comparator | MMF will be prescribed at a starting dose of 1.5 g/day and increased to 2 g/day at week 4 (if body weight ≥ 45 kg) and continue the same dose until week 24. After week 24, MMF will be lowered to 1.5 g/day. Receives: Drug: Mycophenolate Mofetil |
| CC Arm | Active comparator | MMF will be prescribed at a starting dose of 1.5 g/day. MPA-C0 (trough) level will be measured weekly and MMF dose will be increased by 500 mg/day every week until the MPA-C0 level ≥ 3 mg/L or the MMF dosage is 3000 mg/day. After achieving the targeted MPA-C0 level, the MMF dose adjustment will be allowed only if the MPA-C0 levels are lower than 3 mg/L for two consecutive monitoring visits. After week 12, MMF will be maintained at the same dose until week 48 Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate at 48 week of therapy
Measured: 48 weeks
Secondary outcomes (10)
Adverse events
Measured: 48 weeks
Mycophenolic acid trough levels
Measured: 48 weeks
MPA-area under the curve (AUC) 0-4 hour at 12 week
Measured: 12 weeks
C3 levels
Measured: 48 weeks
Urine IP-10 levels
Measured: 48 weeks
Anti-dsDNA
Measured: 48 weeks
Relapse free survival at 96, 144 and 240 week
Measured: 96, 144 and 240 weeks
eGFR at 96, 144 and 240 week
Measured: 96, 144 and 240 weeks
Progression to CKD stage 3 or more at 96, 144 and 240 week
Measured: 96, 144 and 240 weeks
End stage renal disease at 96, 144 and 240 week
Measured: 96, 144 and 240 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start20 Aug 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Why it stopped: Slow recruitment rate
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Berlin Pharmaceutical Industry
- Responsible party
- Principal investigator, Yingyos Avihingsanon, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920059
- Sponsor's protocol ID
- FDCC lupus
- Status last verified
- Jan 2021
- First submitted
- 1 Apr 2019
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis
- ClinicalTrials.gov ID
- NCT03920059
- Acronym / sponsor ID
- FDCC lupus
- Conditions
- Lupus Nephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Berlin Pharmaceutical Industry
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 18 Apr 2019 (actual)
- 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 randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FD arm | Placebo comparator | Drug: Mycophenolate MofetilMMF will be prescribed at a starting dose of 1.5 g/day and increased to 2 g/day at week 4 (if body weight ≥ 45 kg) and continue the same dose until week 24. After week 24, MMF will be lowered to 1.5 g/day. |
| CC Arm | Active comparator | Drug: Mycophenolate MofetilMMF will be prescribed at a starting dose of 1.5 g/day. MPA-C0 (trough) level will be measured weekly and MMF dose will be increased by 500 mg/day every week until the MPA-C0 level ≥ 3 mg/L or the MMF dosage is 3000 mg/day. After achieving the targeted MPA-C0 level, the MMF dose adjustment will be allowed only if the MPA-C0 levels are lower than 3 mg/L for two consecutive monitoring visits. After week 12, MMF will be maintained at the same dose until week 48 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 year
- Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE
- Active lupus nephritis (both new and flare patients can be included) defined as:
Key exclusion criteria (21 listed)
- Pregnancy or breast feeding
- Child-bearing age women who refuse to use effective birth-control
- Poor compliance
- Estimated-GFR < 20 mL/min/1.73 m2
- Crescentic glomeruli more than 30 percent
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 |
|---|---|---|
| Mycophenolate MofetilDescription Each capsule contains Mycophenolate mofetil 250 mg. Presentation / Packing Cap 250 mg (white to off white powder, light blue/peach hard gelatin, imprinting with "MMF" on cap and "250" on body) x 10 x 10's. Storage Store below 30 degree Celcius. | Drug | CC Arm, FD arm |
Primary outcome
Response rate at 48 week of therapy
Time frame: 48 weeks
10 secondary outcomes
Adverse events
Time frame: 48 weeks
Mycophenolic acid trough levels
Time frame: 48 weeks
MPA-area under the curve (AUC) 0-4 hour at 12 week
Time frame: 12 weeks
C3 levels
Time frame: 48 weeks
Urine IP-10 levels
Time frame: 48 weeks
Anti-dsDNA
Time frame: 48 weeks
Relapse free survival at 96, 144 and 240 week
Time frame: 96, 144 and 240 weeks
eGFR at 96, 144 and 240 week
Time frame: 96, 144 and 240 weeks
Progression to CKD stage 3 or more at 96, 144 and 240 week
Time frame: 96, 144 and 240 weeks
End stage renal disease at 96, 144 and 240 week
Time frame: 96, 144 and 240 weeks
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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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.
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 Mycophenolate Mofetil in people with Lupus Nephritis, run by Chulalongkorn University at 1 site in Thailand.
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 5 inclusion and 21 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: stopped early, as of the sponsor's last update on 1 Feb 2021. 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 Thailand. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
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?
Response rate at 48 week of therapy (time frame: 48 weeks). 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 1 Feb 2021.