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临床试验/EUCTR2006-002107-13-DE
EUCTR2006-002107-13-DE进行中（未招募）不适用

A randomized, multicenter, 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 flare - Mylupus

ovartis Pharma Services AG0 个研究点目标入组 90 人开始时间: 2007年1月9日最近更新:
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适应症
相关药物

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
90
研究概览入排标准研究者记录与标识符相似试验

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

性别
All

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 mont preceding the lupus nephritis flare
  • •-Proteinuria defined as >0.5gm urine protein per gram urine creatinine
  • •- Clinical activity defined by one or more of the following changes in renal function:
  • •serum creatinine>1mg/dl / 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 3m
  • •- Patients having received MMF within the preceding 3m
  • •-Use of monoclonal antibody therapy within the past 30 days
  • •- 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 METHOD OF CONTRACEPTION PRIOR TO STARTING MYFORTIC®, UNLESS COMPLETE ABSTINENCE IS THE CHOSEN METHOD. THE TWO METHOD CAN BE 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
  • •- women of child-bearing potential who are planning to become pregnant
  • •- Use of other investigational drugs within im of enrollment
  • •- History of hypersensitivity to study drugs
  • •- History of malignancy within the past 5 years

研究者

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A randomized, multicenter, open-label, 6-month study... | 临床试验