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

Chulalongkorn University

Status and phase: Terminated; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: mycophenolate sodium; Drug: cyclophosphamide

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01015456

2009-001

HITAP

Lupus Research Unit

CRCN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

1

Experimental group

Description:

Oral mycophenolate sodium 1440 mg per day for 12 months

Treatment:

Drug: mycophenolate sodium

2

Active Comparator group

Description:

Intravenous cyclophosphamide monthly for 6 months

Treatment:

Drug: cyclophosphamide