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

Chulalongkorn University

Status and phase

Completed

Phase 3

Conditions

Lupus Nephritis

Treatments

Drug: Mycophenolate mofetil

Study type

Interventional

Funder types

Other

Identifiers

NCT01042457

2009-002

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

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