CTRI/2024/07/071759尚未招募Unknown
A Study to Identify and Characterise Patients with Chronic Kidney Disease and Proteinuria - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1Male or female aged greater than or equal to 18 years at the time of signing the informed consent
- •2Express interest to participate in a future CKD clinical study
- •3eGFR greater than or equal to 20 to less than 90 mL/ min/ 1.73 m square (eGFRcr[AS], Section 8.2.1) (Delgado et al 2022, Inker et al. 2021)
- •4UACR greater than or equal to 700 mg/g or UPCR greater than or equal to 1000 mg/g based on urine sample at time of screening visit
- •5Receiving RAS inhibitor therapy (ACEi or ARB) that has been at stable dosing for at least 4 weeks. Exceptions from this requirement will be made for participants who are unable to tolerate RAS inhibitor therapy
- •6Provision of signed and dated written informed consent before any study-specific procedures
排除标准
- •1Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
- •2As per investigator judgement, patients who are not suitable and/or stable enough to participate in a phase 3 interventional study (eg, recent hospitalisation for HF, recent cardiac surgery or intervention, heart disease including stroke, life expectancy less than 2 years due to conditions other than renal or CV conditions, unable to commit for personal reasons to a phase 3 trial for up to 4 years)
- •3Known T1DM
- •4Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal)
- •5Known history of solid organ transplantation
- •6Known history or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin) or endothelin receptor antagonists (eg, ambrisentan, atrasentan, bosentan)
- •7Known blood-borne diseases such as specified in Appendix B (category A and B)
- •8Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •9Inability of the patient, in the opinion of the investigator, to understand and/or comply procedures and/or follow-up or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
- •10Known pregnancy at the time for the visit or have an intention to become pregnant
- •11Lupus nephritis, anti-neutrophil cytoplasmic autoantibody vasculitis, minimal change disease, autosomal dominant polycystic kidney disease (polycystic kidney disease), Alport syndrome, patients on renal replacement therapy, or clinical nephrotic syndrome with problematic oedema
- •12Unable to commit for personal reasons to a phase 3 clinical trial of up to 4 years duration
研究者
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