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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01042457
First received: January 4, 2010
Last updated: September 27, 2013
Last verified: September 2013

January 4, 2010
September 27, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01042457 on ClinicalTrials.gov Archive Site
To determine Mycophenolic acid level related side effect. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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.
Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01042457
2009-002
No
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