EUCTR2019-001587-30-GB进行中（未招募）1 期
AZD1656 in Transplantation with Diabetes tO PromoTe Immune TOleraNce - The ADOPTION Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •a)Females or males aged 18 years and above
- •b)Having undergone renal transplantation at the Royal London Hospital within the previous 24 hours
- •c)A pre-transplant diagnosis of Type 2 diabetes
- •d)Provision of written, informed consent prior to any study specific procedures
- •e)In women of childbearing potential* documentation of a negative pregnancy test during admission for renal transplant.
- •*Women of childbearing potential are defined as women following menarche until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as the absence of menses for 12 months without an alternative medical cause.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •a)Unable to consent
- •b)Known allergy/intolerance to AZD1656
- •c)Pregnant or breastfeeding women
- •d)Planning on becoming pregnant/unwilling to use highly effective contraception* during the 3 month treatment period and for 2 weeks afterwards
- •a.In the case of men with sexual partners who are women of childbearing potential: refusal to wear a condom and female partner planning on becoming pregnant/unwilling to use highly effective contraception* during the 3 month treatment period and for 2 weeks afterwards
- •e)Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
- •f)Current or planned use of strong inhibitors of CYP2C8
- •g)Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug
- •*Highly effective contraception methods are defined as those that can achieve a failure rate of <1% per year when used correctly and consistently. These include:
- •Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation – either oral, transvaginal or transdermal
- •Progestogen-only hormonal contraception associated with inhibition of ovulation – either oral, injectable or implantable
- •Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- •Bilateral tubal occlusion
- •Vasectomised partner – provided that the partner is the sole sexual partner of the participant and that the vasectomised partner has received medical assessment of surgical success
- •Sexual abstinence – refrain from heterosexual intercourse for the duration of period defined to be at risk
研究者
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