The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis (CONTROL)

This study has been terminated.
(Data Safety Monitoring Board concerning of the participants' safety)
Sponsor:
Collaborators:
Clinical Research Collaborative Network
Health Intervention and Technology Assessment Program (HITAP)
Information provided by (Responsible Party):
Yingyos Avihingsanon, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01015456
First received: November 17, 2009
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Lupus Nephritis
Drug: mycophenolate sodium
Drug: cyclophosphamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The ratio of patients with declined renal function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to remission [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: January 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral mycophenolate sodium 1440 mg per day for 12 months
Drug: mycophenolate sodium
per oral, twice daily, for 12 months
Other Name: Myfortic
Active Comparator: 2
Intravenous cyclophosphamide monthly for 6 months
Drug: cyclophosphamide
intravenous, monthly, for 6 months
Other Name: Cytoxan

Detailed Description:

In this study, there are two sub-studies in order to define secondary endpoints.

  1. Pharmacokinetics study of Mycophenolic acid
  2. Identify biomarkers for therapy-resistant prediction.
  3. Identify biomarkers for predicting a loss of kidney function.
  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015456

Locations
Thailand
Nopparat Rajathani
Bangkok, Thailand
Khon Kaen University
Khon Kaen, Thailand
Thammasart University
Pathumthani, Thailand
Sponsors and Collaborators
Chulalongkorn University
Clinical Research Collaborative Network
Health Intervention and Technology Assessment Program (HITAP)
Investigators
Principal Investigator: Yingyos Avihingsanon, MD Chulalongkorn University
  More Information

Additional Information:
No publications provided

Responsible Party: Yingyos Avihingsanon, Associate Professor., Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01015456     History of Changes
Other Study ID Numbers: 2009-001, Lupus Research Unit, CRCN, HITAP
Study First Received: November 17, 2009
Last Updated: October 9, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
lupus nephritis
mycophenolate sodium
cyclophosphamide

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014