Clinical trial NCT01042457: Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: trough level
therapeutic drug monitoring
Mycophenolate mofetil
Mycophenolic acid
lupus nephritis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month
timeFrame: 24 weeks
Secondary outcomes:
measure: To determine Mycophenolic acid level related side effect.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Yingyos Avihingsanon, MD
role: STUDY_DIRECTOR
References: