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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Chulalongkorn University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Chulalongkorn University

ClinicalTrials.gov Identifier:

NCT01042457

First received: January 4, 2010

Last updated: April 19, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 4, 2010

Last Updated Date

April 19, 2011

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01042457 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine Mycophenolic acid level related side effect. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lupus Nephritis

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yingyos Avihingsanon, MD	662-256-4251 ext 204	yingyos.a@gmail.com
Contact: Wonngarm Kittanamongkolchai, MD		wonngarm@yahoo.com

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01042457

Other Study ID Numbers ^ICMJE

2009-002

Has Data Monitoring Committee

Responsible Party

Yingyos Avihingsanon, Chulalongkorn University

Study Sponsor ^ICMJE

Chulalongkorn University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Yingyos Avihingsanon, MD

Chulalongkorn University

Information Provided By

Chulalongkorn University

Verification Date

April 2011

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

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