PER-068-21招募中3 期
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Age and Sex
- •5Males and females aged 18 to 70 years of age inclusive, at the time of signing the informed consent
- •Disease Characteristics
- •6Fulfills updated 2019 SLE criteria (Aringer et al 2019). Note that ANA positivity may be historical or determined during Screening. Antinuclear antibody-negative patients will still be eligible for study participation provided confirmatory biopsy findings are available and patient has positivity for anti-dsDNA or anti-Sm (historically or determined during Screening).
- •7Have positive ANA, anti-dsDNA, or anti-Sm test result in sample obtained during Screening
- •8Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol) (mean of 2 spot UPCR [FMV] samples obtained during Screening)
- •9Have active proliferative LN Class III or IV either with or without the presence of Class V (excluding pure Class III[C], IV-S[C], or IV-G[C]) according to the 2003 ISN/RPS classification based on:
- •?renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period
- •10eGFR = 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula)
- •11Adequate peripheral venous access
- •Informed Consent
- •1Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the ICF and in this CSP
- •2Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, Data Privacy Directive in the EU) obtained from the participant prior to performing any protocol-related procedures, including Screening evaluations
- •3In the opinion of the Investigator, must be able to comprehend the ICF and all protocol related assessments, such that the participant can complete all study required documents, procedures, and outcome measures
- •4Completion of Screening procedures within 30 days after signing the ICF
- •14Negative SARS-Cov-2 RT-PCR test result at Screening and no known or suspected COVID-19 infection or exposure between signing the ICF and Week 0 (Day 1). There must be a minimum of 2 weeks between the 2 tests at Screening and Week 0 (Day 1).
- •?If suspected infection or known/suspected exposure: Negative retest result obtained after a minimum of 2 weeks from first test and participant remaining asymptomatic without new exposure.
- •?Note: If positive RT-PCR at Screening: Rescreening may be allowed after 3 months provided no development of severe COVID-19 infection or sequelae.
- •15Body weight = 40.0 kg
- •Female participants:
- •?Negative serum ß-hCG test at Screening (females of childbearing potential only).
- •?Women of childbearing potential must have a negative urine pregnancy test at Week 0 (Day 1), prior to administration of study intervention and prior to the first dose of Sponsor-provided MMF.
- •?Females of childbearing potential
排除标准
- •Prior/Concurrent Clinical Study Experience
- •25Participation in another clinical study with another study intervention (besides anifrolumab) administered within 4 weeks prior to ICF signing or within 5 half-lives of the study intervention used in that clinical study, whichever is longer
- •Diagnostic Assessments
- •26Within 4 weeks of Week 0 (Day 1), any of the following (note: retesting of laboratory test results during Screening may be repeated once):
- •?AST > 2.5 × ULN
- •?ALT > 2.5 × ULN
- •?TBL > ULN (unless due to Gilbert’s syndrome [based on Investigator’s judgment])
- •?Glycosylated hemoglobin > 8% (or > 0.08) at Screening (diabetic participants only)
- •?Neutrophil count < 1 × 103/µL (or < 1.0 × 109/L)
- •?Platelet count < 25 × 103/µL (or < 25 × 109/L)
- •?Hemoglobin < 8 g/dL (or < 80 g/L)
- •Other Exclusions
- •27Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •28Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study intervention or interpretation of participant safety or study results
- •29Lactating or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening through the Follow-up Period 12 weeks following last dose of study intervention and 6 weeks after the last dose of Sponsor-provided MMF (whichever is later)
- •30Spontaneous or induced abortion, still or live birth, or pregnancy = 4 weeks prior to signing the ICF
- •31Current alcohol, drug or chemical abuse, or a history of such abuse within one year before Week 0 (Day 1)
- •32Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period (see Appendix P for guidance)
- •33History of, or current diagnosis of, catastrophic antiphospholipid syndrome within one year prior to signing the ICF. Participants with other degrees of antiphospholipid syndrome adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited to the study.
- •34History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent behavior in the lifetime of the participant
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •1A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening
- •2History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment
- •3History of, or current renal diseases (other than LN) that, in the opinion of the Investigator, could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy)
研究者
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