Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate therapeutic response to MMF treatment in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic acid levels at 1-hour post dose will be monitored monthly up to 6 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chulalongkorn University
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Age 16-60 years.

• 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)

Exclusion Criteria:

Relates to SLE

• 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.

Related to Treatment

• Previous of any Mycophenolate groups in the 3 months prior to screening.

• Treatment with more than 2 g Cyclophosphamide in the last 6 months period prior to screening.

• Receipt of more than 3 g IV pulse methylprednisolone within the last 3 months prior to screening.

• Receipt of prednisolone dose > 30 mg/day for longer than 30 days within last 3 months prior to screening.

Related to General Health

• Pregnancy or breast feeding mothers.

• Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.

• History of cancer, including solid tumors, hematological malignancies and carcinoma.

• History of serious recurrent or chronic infection.

• 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.