CTRI/2024/07/071759
Not yet recruiting
未知
A Study to Identify and Characterise Patients with Chronic Kidney Disease and Proteinuria - NI
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Sponsor
- AstraZeneca AB
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Analysis of clinical characteristics of patients with macadamia nut allergy and identification of the macadamia nut allergensMacadamia nut allergyJPRN-UMIN000024563Tokyo Metropolitan Children's Medical Center7
Completed
Not Applicable
The identification of phenotypes in patients with severe Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease (COPD)emphysema10038716NL-OMON40211niversitair Medisch Centrum Groningen1,000
Completed
Not Applicable
A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin Americaewly Diagnosed Breast CancerBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRPCEC00000329Roche Servicios S.A.
Not yet recruiting
Not Applicable
Collecting the details of the patients using IP case sheets in Ayothidoss Pandithar Hospital of NIS in the year 2017Health Condition 1: null- N/AHealth Condition 2: M256- Stiffness of joint, not elsewhereclassifiedCTRI/2018/06/014515Ayothidoss Pandithar Hospital
Completed
Not Applicable
A Prospective Natural History Study of Patients with Intractable Venous Malformation and Klippel-Trenaunay SyndromeVenous malformation and Klippel-Trenaunay SyndromeJPRN-UMIN000047330ARTham Therapeutics Inc.34