A randomized, multicentre, open-label, 6-month study to explore the efficacy and safety of enteric coated mycophenolate sodium (Myfortic) in combination with two corticosteroid regimens for the treatment of lupus nephritis - Mylupus

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

- male or female with SLE (at least classification 4 of ACR)
- Aged >/ 18years
- Proliferative lupus nephritis cassified as ISN/RPS class III or IV
- Renal biopsy must be performed during the last 24 months preceding the study entry
-Proteinuria defined as >0.5g urine protein per gram urine creatinine at screening and baseline
- Clinical activity defined by one or more of the following changes in renal function:
serum creatinine>1mg/dl (88.4micromol/l),
microscopic haematuria defined as > 5 rbcs per high power field,
presence of cellular casts
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients with calculated creatinine clearance of < 30ml/min (using the Cockcroft-Gault formula)
- Patients having received an iv corticosteroid bolus during the last 3months
- Patients having received MMF within the preceding 3 months
-Use of any antibodies within 6 months
- Pregnant or nursing women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a positive serum ß-HCG pregnancy test (> 5 mIU/ml) within 7 days prior to or at Baseline (visit 1)
- Women of child-bearing potential (WOCBP), defined as all women physiologically
capable of becoming pregnant, including women whose career, lifestyle, or sexual
orientation precludes intercourse with a male partner and women whose partners
have been sterilized by vasectomy or other means, unless if adequate contraception is used as defined below.
WOCBP should begin using two or more of the following acceptable methods of
contraception prior to starting myfortic®, unless complete abstinence is the chosen
method. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include:
diaphragm, condom (by the partner), intrauterine device (copper or hormonal),
sponge or spermicide. Hormonal contraceptives include any marketed contraceptive
agent that includes an estrogen and/or a progestational agent. Patients should be
aware that myfortic® reduces blood levels of the hormones in the oral contraceptive
pill and could theoretically reduce its effectiveness.
Reliable contraception should start 4 weeks prior to beginning myfortic® and be
maintained throughout the study and for 6 weeks after study drug discontinuation.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception.
Woman are considered post-menopausal and not of child bearing potential if they
have had 12 months of natural (spontaneous) amenorrhea with an appropriate
clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months
of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol
< 20 pg/mL or have had surgical bilateral oophorectomy (with or without
hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when
the reproductive status of the woman has been confirmed by follow up hormone level
assessment.
- Use of other investigational drugs within 1 month of enrollment (except for antibodies within 6 months)
- History of hypersensitivity to study drugs or to drugs with similar chemical structures
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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