| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lupus Nephritis | Drug: Mycophenolate Mofetil | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis |
| Actual Study Start Date : | August 20, 2019 |
| Actual Primary Completion Date : | January 30, 2020 |
| Actual Study Completion Date : | January 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: FD arm
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.
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Drug: Mycophenolate Mofetil
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. |
|
Active Comparator: CC Arm
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
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Drug: Mycophenolate Mofetil
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. |
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Active lupus nephritis (both new and flare patients can be included) defined as:
Exclusion Criteria:
Receiving concomitant medication interfering PK of MPA
| Thailand | |
| King Chulalongkorn Memorial Hospital | |
| Bangkok, Please Select, Thailand, 10330 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 1, 2019 | ||||
| First Posted Date ICMJE | April 18, 2019 | ||||
| Last Update Posted Date | February 1, 2021 | ||||
| Actual Study Start Date ICMJE | August 20, 2019 | ||||
| Actual Primary Completion Date | January 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Response rate at 48 week of therapy [ Time Frame: 48 weeks ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis | ||||
| Official Title ICMJE | A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis | ||||
| Brief Summary | A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Lupus Nephritis | ||||
| Intervention ICMJE | Drug: Mycophenolate Mofetil
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. |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Actual Enrollment ICMJE |
2 | ||||
| Original Estimated Enrollment ICMJE |
90 | ||||
| Actual Study Completion Date ICMJE | January 30, 2020 | ||||
| Actual Primary Completion Date | January 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Thailand | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03920059 | ||||
| Other Study ID Numbers ICMJE | FDCC lupus | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Yingyos Avihingsanon, Chulalongkorn University | ||||
| Study Sponsor ICMJE | Chulalongkorn University | ||||
| Collaborators ICMJE | Berlin Pharmaceutical Industry | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Chulalongkorn University | ||||
| Verification Date | January 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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