A Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion With Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects With Immunoglobulin A Nephropathy (IgAN)

Baxalta now part of Shire0 个研究点开始时间: 2015年12月31日最近更新: 2022年2月7日

适应症

试验速览

阶段: 2 期
状态: 撤回
发起方
主要终点: Percent change in proteinuria from Baseline to Week 24

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the efficacy and safety of SM101 in the treatment of Immunoglobulin A nephropathy (IgAN)

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18 years of age or older at the time of screening
•Participant may be of any race or ethnicity
•Participant must have a biopsy-proven diagnosis of IgAN.
•Participant's blood pressure is ≤130/80 mmHg at Screening
•Participant is on maximally tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor and/or angiotensin receptor blocker (ARB) for at least 3 months prior to the baseline visit.
•Participant must present at screening with current proteinuria levels between 1 g/24 h and 3.5 g/24 h, based on spot urine protein-to-creatinine ratio (UPCR)
•Participant must present at screening with an estimated glomerular filtration rate (eGFR) >40mL/min/1.73m^2
•If a female of childbearing potential, participant must have a negative pregnancy test at screening, is not currently breastfeeding, and agrees to employ adequate birth control measures for the duration of the study. Male participants with female partners of childbearing potential must agree to use adequate birth control measures for the duration of the study
•Participant is willing and able to comply with the requirements of this protocol and agrees to sign an informed consent form prior to any study-related activities

排除标准

•Participant has a history or current evidence of renal disease other than IgAN
•Participants with evidence of rapidly progressive disease
•Participant has IgAN with histologic evidence of advanced tubular atrophy and interstitial
•History or current evidence of other autoimmune disease
•History or current evidence of any chronic or uncontrolled medical condition which could, in the opinion of the Investigator, affect the participant's safety and ability to adhere to this protocol
•History or current evidence of a severe acute or chronic infection
•Use of systemic corticosteroids within 3 months prior to baseline, or anticipated use during the treatment period (Week 1 through Week 4). Note: Corticosteroids administered by inhalation or intranasally, or limited topical use of low-potency topical corticosteroids are allowed throughout the study.
•Known hypersensitivity or allergic reaction to any E. coli-derived recombinant product, yeast extract, or to the IP or any of its excipients
•Treatment with any immunomodulatory/immunosuppressive compound or monoclonal antibody for any indication within 6 months (unless otherwise stated) prior to screening (eg, B cell-depleting agents [eg, rituximab, epratuzumab] for ≥48 weeks; B-cell modifying agents [eg, belimumab, atacicept] for ≥24 weeks; IV immunoglobulins for ≥12 weeks and all other immunosuppressive treatments [eg, methotrexate, cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine] for ≥12 weeks)
•Clinically significant laboratory abnormalities prior to baseline
•History of any malignancy within past 5 years prior to screening (except for basal and squamous cell carcinomas of the skin, in situ cervical cancer, and stable prostate cancer that does not require treatment)
•History of tonsillectomy within 2 months prior to screening
•Participation in another clinical study involving an IP or investigational device within 30 days prior to screening or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
•Participant is a family member or employee of the Investigator
•A female participant who is pregnant or nursing at the time of screening

结局指标

主要结局

Percent change in proteinuria from Baseline to Week 24

时间窗: Baseline and Week 24

次要结局

Number of infusions that had to be slowed, interrupted, or terminated due to adverse events (AEs) or serious adverse events (SAEs)(Throughout the study period of approximately 19 months)
Pharmacokinetics: time of maximum observed concentration (Cmax)(Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.)
Number of participants who experience serious adverse events (SAEs) or adverse events (AEs)(Throughout the study period of approximately 19 months)
Number of participants with any clinically significant change in vital signs during investigational product (IP) administration or within 30 minutes following administration(Baseline through 30 minutes following IP administration)
Number of infusions associated with adverse events (AEs) or serious adverse events (SAEs) , regardless of causality(Throughout the study period of approximately 19 months)
Pharmacokinetics: maximum observed concentration (Cmax)(Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.)
Clinically significant abnormal laboratory assessments(Throughout the study period of approximately 19 months)
Pharmacokinetics: volume of distribution at the terminal phase (Vz)(Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.)
Number of participants who demonstrate a ≥30% reduction from Baseline in proteinuria(Baseline, Week 8, Week 12, Week 18, and Week 24)
Number of participants who experience any treatment-related serious adverse event (SAE) or severe adverse events (AE) during the course of the treatment period or subsequent follow-up period(Throughout the study period of approximately 19 months)
Number of participants who experience temporally-related adverse events (AEs)(Baseline through 72 hours of IP administration)
Number of participants who reach and maintain proteinuria levels below 1.0 g/24 h(Week 8, Week 12, Week 18, and Week 24)
Mean change from Baseline in Estimated glomerular filtration rate (eGFR)(Baseline, Week 8, Week 12, Week 18, and Week 24)
Number of participants with detectable levels of antidrug antibodies (ADAs)(Baseline, Week 3, Week 4, Week 12, Week 24, or early termination from the study)
Pharmacokinetics: terminal half-life (t1/2)(Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.)
Pharmacokinetics: systemic clearance (CL)(Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.)
Pharmacokinetics: volume of distribution at steady state (Vss)(Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.)
Pharmacokinetics: area under the concentration-time curve during a dosing interval (AUC(0-tau))(Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours.)

研究者

发起方

Baxalta now part of Shire

申办方类型

Industry

责任方

Sponsor

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