Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis

Chulalongkorn University

Status and phase: Terminated; Phase 4

Conditions: Lupus Nephritis

Treatments: Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT03920059

FDCC lupus

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups, including a placebo group

FD arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Mycophenolate Mofetil

CC Arm

Active Comparator group

Description:

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

Treatment:

Drug: Mycophenolate Mofetil