NCT04342325已完成1 期
Open-label, Multiple-center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 for the Treatment for Immunoglobulin A (IgA) Nephropathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and the tolerability of ADR-001 in Immunoglobulin A (IgA) Nephropathy patients. In addition, the investigators will evaluate the efficacy of ADR-001 for IgA Nephropathy patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgA nephropathy diagnosed by renal biopsy.
- •Meet any of the following criteria.
- •i. Urinary protein at screening is 0.5 g / gCr or more and eGFR is 60 mL / min / 1.73m^2 or more even if corticosteroids are used for 6 months or more before screening.
- •ii. Urine protein of 1.0 g / gCr or more and eGFR of 30 mL / min / 1.73 m^2 or more and less than 60 mL / min / 1.73 m^2 at screening even if corticosteroids are used for 6 months or more before screening.
- •iii. Urine protein of 0.5 g / gCr or more and less than 1.0 g / gCr at screening and eGFR of 20 mL / min / 1.73m^2 or more and 60 mL / min / 1.73m^2 or urine protein of 1.0 g / gCr or more at screening And eGFR is 20 mL / min / 1.73m^2 or more and less than 30 mL / min / 1.73m^
- •Over 20 years old.
- •Able to provide informed consent.
- •However, in the first cohort, only 2) -i is applied in the selection criteria 2), and in the second cohort, 2) -i, ii, and iii are applied.
排除标准
- •Nephropathy other than IgA nephropathy, and primary and secondary nephrotic syndrome.
- •Start or increase drug therapy for IgA nephropathy with corticosteroids, immunosuppressants, renin angiotensin system (RAS ) inhibitors, antiplatelet drugs, anticoagulants (warfarin), and n-3 fatty acids (fish oil) within 3 months . Palatal tonsillectomy within 6 months.
- •Treatment with other cells.
- •Participated within 3 months or participating in other clinical trials .
- •Penal transplantation within 3 years or scheduled.
- •Diabetics not well controlled.
- •Malignant neoplasm or history of malignant neoplasm within 5 years, or judged possibility of malignant tumor.
- •Suspected of active infection.
- •Positive for hepatitis B (HB), hepatitis C virus (HCV),human Immunodeficiency virus (HIV), human T-cell leukemia virus 1 (HTLV-1) or syphilis.
- •History of severe hypersensitivity or anaphylactic reaction.
- •Allergic to penicillin antibiotics, aminoglycoside antibiotics or dimethyl sulfoxide (DMSO).
- •Serious complications not related to IgA nephropathy.
- •Bleeding or may bleed, shallow days after surgery or trauma to the central nervous system, history of hypersensitivity to components of heparin preparations, history of heparin-induced thrombocytopenia Previous patient.
- •During pregnancy, lactation, may be pregnant or both men and women who do not agree to give birth control under the guidance of the investigator or investigator during the study period.
结局指标
主要结局
Incidence of adverse events
时间窗: until 6 weeks after first administration
Any adverse events are summarized.
次要结局
- Proteinuria(at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration)
- Estimated glomerular filtration rate (eGFR)(at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration)
- Hematuria(at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration)
- Clinical remission (proteinuria, hematuria)(at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration)
研究者
Shoichi Maruyama MD PhD
Professor at Department of Nephrogy, Graduate school of Medicine
Nagoya University
研究点 (4)
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