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

NCT ID: NCT01015456

Last Updated: 2014-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-01-31

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.

1. Pharmacokinetics study of Mycophenolic acid

2. Identify biomarkers for therapy-resistant prediction.

3. Identify biomarkers for predicting a loss of kidney function.

Conditions

Lupus Nephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Oral mycophenolate sodium 1440 mg per day for 12 months

Group Type: EXPERIMENTAL

mycophenolate sodium

Intervention Type: DRUG

per oral, twice daily, for 12 months

2

Intravenous cyclophosphamide monthly for 6 months

Group Type: ACTIVE_COMPARATOR

cyclophosphamide

Intervention Type: DRUG

intravenous, monthly, for 6 months

Interventions

mycophenolate sodium

per oral, twice daily, for 12 months

Intervention Type: DRUG

cyclophosphamide

intravenous, monthly, for 6 months

Intervention Type: DRUG

Other Intervention Names

Myfortic; Cytoxan

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Research Collaborative Network

NETWORK

Sponsor Role: collaborator

Health Intervention and Technology Assessment Program (HITAP)

UNKNOWN

Sponsor Role: collaborator

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Yingyos Avihingsanon

Associate Professor.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yingyos Avihingsanon, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Nopparat Rajathani

Bangkok, , Thailand

Thammasart University

Pathum Thani, , Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 26835147 (View on PubMed)

Related Links

http://www.lupus.research.chula.ac.th/

Lupus Research Unit

Other Identifiers

Lupus Research Unit

Identifier Type: -

Identifier Source: secondary_id

CRCN

Identifier Type: -

Identifier Source: secondary_id

HITAP

Identifier Type: -

Identifier Source: secondary_id

2009-001

Identifier Type: -

Identifier Source: org_study_id