NCT01042457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 30, 2013

Status Verified

September 1, 2013

Enrollment Period

2.6 years

First QC Date

January 4, 2010

Last Update Submit

September 27, 2013

Conditions

Lupus Nephritis

Keywords

trough leveltherapeutic drug monitoringMycophenolate mofetilMycophenolic acidlupus nephritis

Outcome Measures

Primary Outcomes (1)

  • Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month

    24 weeks

Secondary Outcomes (1)

  • To determine Mycophenolic acid level related side effect.

    24 weeks

Study Arms (1)

Mycophenolate mofetil

OTHER
Drug: Mycophenolate mofetil

Interventions

Mycophenolate mofetilDRUG

Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.

Also known as: cellcept
Mycophenolate mofetil

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, Bangkok, Thailand

Location

Related Links

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Yingyos Avihingsanon, MD

    Chulalongkorn University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

May 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 30, 2013

Record last verified: 2013-09

Locations

TH(1)