Clinical trial NCT03920059: Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis
Official title: A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lupus Nephritis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Berlin Pharmaceutical Industry
First posted: 2019-04-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.


Eligibility criteria: 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

Primary outcomes:
measure: Response rate at 48 week of therapy
timeFrame: 48 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 48 weeks
measure: Mycophenolic acid trough levels
timeFrame: 48 weeks
measure: MPA-area under the curve (AUC) 0-4 hour at 12 week
timeFrame: 12 weeks
measure: C3 levels
timeFrame: 48 weeks
measure: Urine IP-10 levels
timeFrame: 48 weeks
measure: Anti-dsDNA
timeFrame: 48 weeks
measure: Relapse free survival at 96, 144 and 240 week
timeFrame: 96, 144 and 240 weeks
measure: eGFR at 96, 144 and 240 week
timeFrame: 96, 144 and 240 weeks
measure: Progression to CKD stage 3 or more at 96, 144 and 240 week
timeFrame: 96, 144 and 240 weeks
measure: End stage renal disease at 96, 144 and 240 week
timeFrame: 96, 144 and 240 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Please Select
Study officials:
References: