The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis (CONTROL)

Inclusion Criteria:

• age 16 years of above at the time of screening
• ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements
• Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening
• Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (>90% chronic irreversible scarring)
• Relapse or resistant to (3 consecutive doses) IVCY

• Resistant lupus or Relapse lupus nephritis defined as follows:

  • Increase in serum creatinine >/= 0.3 mg/dl or
  • Increase in proteinuria > 1.5 g/day (which must have improved by ≥ 50% in the preceding 3 months)
• Life-time cumulative dose of IVCY > 6 grams
• Female patients of childbearing potential must have a negative serum pregnancy

Exclusion Criteria:

Relates to SLE

• Diagnosis of rapid progressive glomerulonephritis (RPGN): doubling serum creatinine and/or crescentic glomeruli ≥ 30%
• Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR < 30 ml/min(except creatinine clearance or MDRD-GFR > 50 ml/min in the 12 weeks prior to screening)
• History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.
• Severe extra-renal organ involvement

Related to Treatment

• Previous of any Mycophenolate groups in the 6 months prior to screening
• Treatment with any investigational drugs in the 3 months prior to screening

Related to General Health

• Pregnancy or breast feeding mothers.
• Concomitant condition which has required treatment moderate to high dose steroid in the 12 weeks prior to screening.
• Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.
• History of cancer, including solid tumors, hematological malignancies and carcinoma.
• Evidence of current abuse of drugs or alcohol.

Related to Laboratory Findings

• Neutrophile < 1,500/mm3, Hb < 7g/L, Platelet < 50,000/mm3 (except active SLE)
• Positive HBsAg or anti-HCV or anti-HIV.