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

Phase 3

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: Mycophenolate mofetil

• Registration Number: NCT01042457
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mycophenolate mofetil	Mycophenolate mofetil	-

Primary Outcome Measures

Name	Time	Method
Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month	24 weeks

Secondary Outcome Measures

Name	Time	Method
To determine Mycophenolic acid level related side effect.	24 weeks

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand