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

November 17, 2009
October 9, 2014
January 2010
January 2013   (final data collection date for primary outcome measure)
Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01015456 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lupus Nephritis
  • Drug: mycophenolate sodium
    per oral, twice daily, for 12 months
    Other Name: Myfortic
  • Drug: cyclophosphamide
    intravenous, monthly, for 6 months
    Other Name: Cytoxan
  • Experimental: 1
    Oral mycophenolate sodium 1440 mg per day for 12 months
    Intervention: Drug: mycophenolate sodium
  • Active Comparator: 2
    Intravenous cyclophosphamide monthly for 6 months
    Intervention: Drug: cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
59
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01015456
2009-001, Lupus Research Unit, CRCN, HITAP
No
Yingyos Avihingsanon, Chulalongkorn University
Chulalongkorn University
  • Clinical Research Collaborative Network
  • Health Intervention and Technology Assessment Program (HITAP)
Principal Investigator: Yingyos Avihingsanon, MD Chulalongkorn University
Chulalongkorn University
October 2014

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