search
Back to results

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

Primary Purpose

Lupus Nephritis

Status
Terminated
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
mycophenolate sodium
cyclophosphamide
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 lupus nephritis, mycophenolate sodium, cyclophosphamide

Eligibility Criteria

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

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.

Sites / Locations

  • Nopparat Rajathani
  • Khon Kaen University
  • Thammasart University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Oral mycophenolate sodium 1440 mg per day for 12 months

Intravenous cyclophosphamide monthly for 6 months

Outcomes

Primary Outcome Measures

Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis

Secondary Outcome Measures

The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment
The ratio of patients with declined renal function
Time to remission

Full Information

First Posted
November 17, 2009
Last Updated
October 9, 2014
Sponsor
Chulalongkorn University
Collaborators
Clinical Research Collaborative Network, Health Intervention and Technology Assessment Program (HITAP)
search

1. Study Identification

Unique Protocol Identification Number
NCT01015456
Brief Title
The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis
Acronym
CONTROL
Official Title
The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Data Safety Monitoring Board concerning of the participants' safety
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
Clinical Research Collaborative Network, Health Intervention and Technology Assessment Program (HITAP)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
lupus nephritis, mycophenolate sodium, cyclophosphamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Oral mycophenolate sodium 1440 mg per day for 12 months
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intravenous cyclophosphamide monthly for 6 months
Intervention Type
Drug
Intervention Name(s)
mycophenolate sodium
Other Intervention Name(s)
Myfortic
Intervention Description
per oral, twice daily, for 12 months
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
intravenous, monthly, for 6 months
Primary Outcome Measure Information:
Title
Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment
Time Frame
12 months
Title
The ratio of patients with declined renal function
Time Frame
12 months
Title
Time to remission
Time Frame
12 months

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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingyos Avihingsanon, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nopparat Rajathani
City
Bangkok
Country
Thailand
Facility Name
Khon Kaen University
City
Khon Kaen
Country
Thailand
Facility Name
Thammasart University
City
Pathumthani
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26835147
Citation
Anutrakulchai S, Panaput T, Wongchinsri J, Chaishayanon S, Satirapoj B, Traitanon O, Pima W, Rukrung C, Thinkhamrop B, Avihingsanon Y. A multicentre, randomised controlled study of enteric-coated mycophenolate sodium for the treatment of relapsed or resistant proliferative lupus nephritis: an Asian experience. Lupus Sci Med. 2016 Jan 14;3(1):e000120. doi: 10.1136/lupus-2015-000120. eCollection 2016.
Results Reference
derived
Links:
URL
http://www.lupus.research.chula.ac.th/
Description
Lupus Research Unit

Learn more about this trial

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

We'll reach out to this number within 24 hrs