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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01042457
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : September 30, 2013
Information provided by (Responsible Party):
Chulalongkorn University

January 4, 2010
January 5, 2010
September 30, 2013
May 2009
December 2011   (Final data collection date for primary outcome measure)
Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT01042457 on Archive Site
To determine Mycophenolic acid level related side effect. [ Time Frame: 24 weeks ]
Same as current
Not Provided
Not Provided
Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis
Not Provided
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.
Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lupus Nephritis
Drug: Mycophenolate mofetil
Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.
Other Name: cellcept
Mycophenolate mofetil
Intervention: Drug: Mycophenolate mofetil
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 60 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Chulalongkorn University
Chulalongkorn University
Not Provided
Study Director: Yingyos Avihingsanon, MD Chulalongkorn University
Chulalongkorn University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP