EUCTR2015-001750-15-AT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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 methods of birth control per ICH M3 (R2) 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 treatment.
- •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: 0
- •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
- •Acute presence of Oliguria (<500 mL/day)
- •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 acceptable.
- •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
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