EUCTR2006-002107-13-GB进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- 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
排除标准
- •- 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
研究者
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