- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03920059
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 the Treatment of Active Lupus Nephritis
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Please Select
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Bangkok, Please Select, Thailand, 10330
- King Chulalongkorn Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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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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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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Response rate at 48 week of therapy
Time Frame: 48 weeks
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48 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Adverse events
Time Frame: 48 weeks
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48 weeks
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Mycophenolic acid trough levels
Time Frame: 48 weeks
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48 weeks
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MPA-area under the curve (AUC) 0-4 hour at 12 week
Time Frame: 12 weeks
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12 weeks
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C3 levels
Time Frame: 48 weeks
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48 weeks
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Urine IP-10 levels
Time Frame: 48 weeks
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48 weeks
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Anti-dsDNA
Time Frame: 48 weeks
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48 weeks
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Relapse free survival at 96, 144 and 240 week
Time Frame: 96, 144 and 240 weeks
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96, 144 and 240 weeks
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eGFR at 96, 144 and 240 week
Time Frame: 96, 144 and 240 weeks
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96, 144 and 240 weeks
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Progression to CKD stage 3 or more at 96, 144 and 240 week
Time Frame: 96, 144 and 240 weeks
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96, 144 and 240 weeks
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End stage renal disease at 96, 144 and 240 week
Time Frame: 96, 144 and 240 weeks
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96, 144 and 240 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Mycophenolic Acid
Other Study ID Numbers
- FDCC lupus
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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