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

Lupus Nephritis Clinical Trial

— CONTROL  

Official title:

The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01015456
• Other study ID #: 2009-001
• Secondary ID: Lupus Research U
• Status: Terminated
• Phase: Phase 3
• First received: November 17, 2009
• Last updated: October 9, 2014
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: October 2014
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• mycophenolate sodium
per oral, twice daily, for 12 months
• cyclophosphamide
intravenous, monthly, for 6 months

Locations

Country	Name	City	State
Thailand	Nopparat Rajathani	Bangkok
Thailand	Khon Kaen University	Khon Kaen
Thailand	Thammasart University	Pathumthani

Sponsors (3)

Lead Sponsor	Collaborator
Chulalongkorn University	Clinical Research Collaborative Network, Health Intervention and Technology Assessment Program (HITAP)

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis		12 months	Yes
Secondary	The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment		12 months	No
Secondary	The ratio of patients with declined renal function		12 months	No
Secondary	Time to remission		12 months	No

External Links

•   Lupus Research Unit