Observational study on chronic kidney disease in Spain
A Multinational, Observational, Retrospective, Secondary Data Study Describing Management and Treatment in Routine Clinical Practice Among Patients With Chronic Kidney Disease. Local Adaptation for Spain. Part 1
This study looks at how common chronic kidney disease is in Spain and how well kidney-protective treatments are being used among patients from 2020 to 2024.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 86516 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 1 site (Sevilla) |
| Trial ID | NCT06614712 on ClinicalTrials.gov |
What this trial studies
The OPTIMISE-CKD study is a retrospective observational analysis that evaluates the incidence of renal disease, specifically chronic kidney disease (CKD), using laboratory measurements such as eGFR and UACR, along with diagnostic codes. It aims to assess the occurrence of cardiovascular and renal events in the population and the current utilization of kidney-protective treatments. The study will analyze data from 2020 to 2024 to provide insights into the clinical landscape of CKD in Spain.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with evidence of renal impairment or a diagnosis of chronic kidney disease.
Not a fit: Patients with stage 5 CKD, those on dialysis, organ transplant recipients, or individuals with type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of CKD incidence and treatment patterns, potentially leading to improved patient management and outcomes.
How similar studies have performed: Other observational studies have successfully assessed CKD incidence and treatment patterns, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age ≥18 years as of study index date * With renal function measured as either of the following: * At least 1 UACR measure of ≥30 mg/g; OR * At least 2 eGFR measures taken ≥90 days apart, of which both eGFR is ≤75 ml/min/1.73m2 ; OR * registered with Chronic Kidney Disease (CKD) diagnosis in the medical history (without biochemical confirmation) Exclusion Criteria: * History of stage 5 CKD, dialysis, organ transplant, type 1 diabetes, or gestational diabetes on or before the start date of the observation period
Where this trial is running
Sevilla
- Research Site — Sevilla, Spain (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.