- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01015456
The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis (CONTROL)
October 9, 2014 updated by: Yingyos Avihingsanon, Chulalongkorn University
The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis
To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis.
The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
In this study, there are two sub-studies in order to define secondary endpoints.
- Pharmacokinetics study of Mycophenolic acid
- Identify biomarkers for therapy-resistant prediction.
- Identify biomarkers for predicting a loss of kidney function.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bangkok, Thailand
- Nopparat Rajathani
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Khon Kaen, Thailand
- Khon Kaen University
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Pathumthani, Thailand
- Thammasart University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 16 years of above at the time of screening
- 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)
- Relapse or resistant to (3 consecutive doses) IVCY
Resistant lupus or Relapse lupus nephritis defined as follows:
- Increase in serum creatinine >/= 0.3 mg/dl or
- Increase in proteinuria > 1.5 g/day (which must have improved by ≥ 50% in the preceding 3 months)
- Life-time cumulative dose of IVCY > 6 grams
- Female patients of childbearing potential must have a negative serum pregnancy
Exclusion Criteria:
Relates to SLE
- Diagnosis of rapid progressive glomerulonephritis (RPGN): doubling serum creatinine and/or crescentic glomeruli ≥ 30%
- 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.
- Severe extra-renal organ involvement
Related to Treatment
- Previous of any Mycophenolate groups in the 6 months prior to screening
- Treatment with any investigational drugs in the 3 months prior to screening
Related to General Health
- Pregnancy or breast feeding mothers.
- Concomitant condition which has required treatment moderate to high dose steroid in the 12 weeks prior to screening.
- Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.
- History of cancer, including solid tumors, hematological malignancies and carcinoma.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Oral mycophenolate sodium 1440 mg per day for 12 months
|
per oral, twice daily, for 12 months
Other Names:
|
Active Comparator: 2
Intravenous cyclophosphamide monthly for 6 months
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intravenous, monthly, for 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment
Time Frame: 12 months
|
12 months
|
The ratio of patients with declined renal function
Time Frame: 12 months
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12 months
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Time to remission
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yingyos Avihingsanon, MD, Chulalongkorn University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
November 17, 2009
First Submitted That Met QC Criteria
November 17, 2009
First Posted (Estimate)
November 18, 2009
Study Record Updates
Last Update Posted (Estimate)
October 10, 2014
Last Update Submitted That Met QC Criteria
October 9, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cyclophosphamide
- Mycophenolic Acid
Other Study ID Numbers
- 2009-001
- Lupus Research Unit
- CRCN
- HITAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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