ISRCTN49958194已完成未知
An Investigation into the Efficacy of Mirococept (APT070) for Preventing Ischaemia-Reperfusion Injury in the Kidney ALlograft (EMPIRIKAL)
King?s College London (UK)0 个研究点目标入组 560 人开始时间: 2012年8月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 560
研究概览
简要总结
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28587616 2021 results in https://pubmed.ncbi.nlm.nih.gov/33225626/ (added 12/04/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria as of 21/04/2016:
- •1. Aged 16 years or older
- •2. Registered on the kidney transplant list
- •3. Willing to participate in the study and provide written informed consent
- •4. Must have the ability to comply with the study requirements
- •5. Patient is on dialysis
- •6. Receiving kidney from a donor over 10 years of age
- •Original inclusion criteria:
- •1. Patient must be 16 years of age or older
- •2. Patient must be willing to participate in the study & provide written informed consent
- •3. Patient must have the ability to comply with the study requirements
- •4. Donor must be older than 10 years of age
排除标准
- •Exclusion criteria as of 21/04/2016:
- •1. Patient is recipient of a living-donor kidney
- •2. Patient is a recipient of a DCD kidney Maastricht category 1 or 2
- •3. Patient has evidence of current infection with HIV, HBV or HCV
- •4. Patient is recipient of a paediatric en bloc or a adult double renal transplant
- •5. Any recipient of a multi-organ transplant or a previous recipient of a non-renal solid organ transplant
- •6. Females who are pregnant or lactating
- •7. Male and Female patients not willing to use contraception for at least one month post-transplant
- •8. Any planned ABO blood group or HLA antibody incompatible transplant
- •9. Patient is involved in other experimental drug trials
- •Original exclusion criteria:
- •1. Patient is recipient of a living-donor kidney
- •2. Patient is not yet on dialysis
- •3. Patient is a recipient of a Donation after Cardiac Death (DCD) kidney Maastricht category 1 or 2
- •4. Patient has evidence of current or previous infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)
- •5. Patient is recipient of an en bloc double renal transplant
- •6. The donor kidney has more than 2 renal arteries, unless the artery is small enough to be ligated and not perfused.
- •7. Any ABO or HLA incompatible transplant
- •8. Patients receiving donor organs with a cold ischaemic time >30 hours
- •9. Any recipient of a multi-organ transplant or a previous recipient of a non-renal solid organ transplant
- •10. Females who are pregnant or lactating
- •11. Patients not willing to use contraception for at least one month post transplant
- •12. Patients with a history of malignancy within the last 5 years, except adequately treated squamous or basal cell carcinomas of the skin or cervical intraepithelial neoplasia
- •13. Patients involved in other experimental drug trials
- •14. Patients who might be expected to have an allergic response to the molecule
研究者
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