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

C

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

  • Neutrophile < 1,500/mm3, Hb < 7g/L, Platelet < 50,000/mm3 (except active SLE)
  • Positive HBsAg or anti-HCV or anti-HIV.

Trial design

24 participants in 1 patient group

Mycophenolate mofetil
Other group
Treatment:
Drug: Mycophenolate mofetil

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems