Study to Identify and check Patients with Chronic Kidney Disease and Proteinuria
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2024/07/071759
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To identify and characterise patients with CKD and high proteinuria. Below parameters are assessed. <br/ ><br> <br/ ><br>Age <br/ ><br>Sex <br/ ><br>T2DM (Y/N) <br/ ><br>HF + NYHA class (if known) <br/ ><br>ACEi (Y/N) <br/ ><br>ARB (Y/N) <br/ ><br>SGLT2i (Y/N) <br/ ><br>CKD aetiology <br/ ><br>eGFR <br/ ><br>UACR <br/ ><br>UPCRTimepoint: Summary statistics assessed at one single visit (at visit 1 which is one day) <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method To obtain an overview on current medication for patients with CKD & high proteinuria across different geographical regionsTimepoint: Summary statistics assessed at one single visit (at visit 1 which is one day)