EUCTR2015-001750-15-IT进行中（未招募）1 期
A double-blind, randomised, placebo-controlled trial evaluating the effect of BI 655064 administered as sub-cutaneous injections, on renal response after one year treatment in patients with lupus nephritis - POC in lupus nephrits
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 160 人开始时间: 2020年11月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •males and females 18-70 years. Women of childbearing potential* must
- •be ready and able to use simultaneously two reliable methods of birth
- •control, one of which must be highly effective. Highly effective method,
- •per ICH M3 (R2) is a method that result in a low failure rate of less than
- •1% per year when used consistently and correctly. The reliable
- •contraception should be used before starting MMF therapy and the study
- •drug, during the treatment and until 50 days after stopping MMF and the
- •study drug. Sexually active men must be ready to use condoms during
- •treatment with MMF and for at least 90 days after cessation of MMF
- •Diagnosis of systemic lupus erythematosus (SLE) by ACR criteria 1997,
- •at least 4 criteria must be documented, one of which must be a positive
- •anti-dsDNA antibody or a positive antinuclear antibody (ANA) at
- •screening or around time of start of induction therapy
- •Lupus Nephritis Class III or IV (ISN/RPS 2003 classification) with either
- •active or active/chronic disease, co-existing class V permitted, proven
- •by renal biopsy within 3 months prior to screening or during screening if
- •induction therapy has not yet been started
- •Active renal disease evidenced by proteinuria >= 1.0 g/day
- •(Uprot/Ucrea >= 1) at screening
- •Signed and dated written informed consent
- •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 109
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •clinically significant current other renal disease
- •GFR<30ml/min/1.73m²
- •Dialysis within 12m of screening
- •Antiphospholipid syndrom defined as positive antiphospholipid
- •antibodies and either history of any thrombotic event and or history of
- •miscarriage.
- •diabetes mellitus poorly controlled or known diabethic retinopathy or
- •nephropathy
- •Evidence of current or previous clinically significant disease, medical
- •condition or finding in the medical examination that in the investigator's
- •opinion would compromise the safety of the patient or the quality of the
- •Any induction therapy for LN within the last 6 months prior to
- •randomisation except induction with MMF and high dose steroids tarted
- •within 6 weeks prior to randomisation. If a higher dose of iv steroids is
- •considered necessary by the investigator a total dose of up to 3g is
- •Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20,
- •anti-CD22) within 12 months prior to randomisation
- •Treatment with Belimumab or other anti BLyS: when used for treatment
- •of non-renal SLE 3 months or 5 half lives whichever is longer, prior to
- •randomisation ; when used for treatment of Lupus nephrits: 12 months
- •prior to randomisation
- •Treatment with abatacept within 12 months prior to randomisation
- •Treatment with tacrolimus or cyclosporin within 4 weeks prior to
- •randomisation
- •Treatment with cyclophosphamid within 6 months prior to randomisation
- •Treatment with investigational drug within 6 months or 5 half-lives,
- •whichever is greater before randomisation
- •Contraindication for MMF or corticosteroids and/or known
- •hypersensitivity to any constituents of the study drug
- •Live vaccination within 6 weeks before randomisation
- •Chronic or relevant acute infections, including but not limited to HIV,
- •Hepatitis B and C and tuberculosis (including a history of clinical TB
- •and/or a positive QuantiFERON TB-Gold test)
- •Any active or suspected malignancy or history of documented
- •malignancy within the last 5 years before screening, except
- •appropriately treated carcinoma in situ and treated basal cell carcinoma.
- •Patients unable to comply with the protocol in the investigator¿s
- •Alcohol abuse in the opinion of the investigator or active drug abuse .
- •Women who are pregnant, nursing, or who plan to become pregnant
- •while in the trial
- •Impaired hepatic function, defined as serum AST/ALT, bilirubin or
- •alkaline phosphatase levels > 2 x ULN
- •Significant central nervous system symptoms related to SLE based on
- •investigator assessment
研究者
相似试验
招募中
3 期
Melatonin supplementation effect on the Induction of labour rates in first-time MothErs:The MyTIME TrialInduction of labourReproductive Health and Childbirth - Childbirth and postnatal careACTRN12623000502639Curtin University530
进行中（未招募）
不适用
A double-blind, randomised, placebo-controlled trial confirming the efficacy of intranasal fentanyl titrated to 50, 100 or 200 µg with an open long-term safety follow-up in cancer patients with breakthrough paiBreakthrough PainMedDRA version: 8.1Level: PTClassification code 10064556EUCTR2005-002348-24-DKycomed Danmark ApS200
进行中（未招募）
不适用
A double-blind, randomised, placebo-controlled trial confirming the efficacy of intranasal fentanyl titrated to 50, 100 or 200 µg with an open long-term safety follow-up in cancer patients with breakthrough paiBreakthrough PainMedDRA version: 8.1Level: PTClassification code 10064556EUCTR2005-002348-24-DEycomed Danmark ApS200
进行中（未招募）
1 期
Efficacy and safety of BI 655064 in patients with active lupus nephritisupus NephritisMedDRA version: 19.0Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2015-001750-15-GRBoehringer Ingelheim Ellas SA160
进行中（未招募）
不适用
A double-blind, randomised, placebo-controlled trial confirming the efficacy of intranasal fentanyl titrated to 50, 100 or 200 µg with an open long-term safety follow-up in cancer patients with breakthrough paiBreakthrough PainMedDRA version: 8.1Level: PTClassification code 10064556EUCTR2005-002348-24-FIycomed Danmark ApS200