search
Back to results

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

Primary Purpose

Lupus Nephritis

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Mycophenolate mofetil
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring trough level, therapeutic drug monitoring, Mycophenolate mofetil, Mycophenolic acid, lupus nephritis

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chulalongkorn University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Mycophenolate mofetil

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To determine Mycophenolic acid level related side effect.

Full Information

First Posted
January 4, 2010
Last Updated
September 27, 2013
Sponsor
Chulalongkorn University
search

1. Study Identification

Unique Protocol Identification Number
NCT01042457
Brief Title
Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
trough level, therapeutic drug monitoring, Mycophenolate mofetil, Mycophenolic acid, lupus nephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mycophenolate mofetil
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Other Intervention Name(s)
cellcept
Intervention Description
Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.
Primary Outcome Measure Information:
Title
Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
To determine Mycophenolic acid level related side effect.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingyos Avihingsanon, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Study Director
Facility Information:
Facility Name
Chulalongkorn University
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.lupus.research.chula.ac.th/
Description
(Lupus Research Unit)

Learn more about this trial

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

We'll reach out to this number within 24 hrs