Concentration-controlled Therapy of Mycophenolate Mofetil... | NCT01042457

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

NCT01042457

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Sep 30, 2013Estimated

Enrollment

24Actual

Phase

Phase 3

Conditions

Lupus Nephritis

Interventions

Mycophenolate mofetil

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jan 4, 2010

First Submission Date that Met QC Criteria

Jan 4, 2010

First Posted Date

Jan 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2013

Last Update Posted Date

Sep 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Label	Type	Description	Intervention Names
Mycophenolate mofetil	Other		Drug: Mycophenolate mofetil

Name	Type	Description	Arm Group Labels	Other Names
Mycophenolate mofetil	Drug	Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.	Mycophenolate mofetil

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

Measure	Description	Time Frame
To determine Mycophenolic acid level related side effect.		24 weeks

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals