Overview
Chronic kidney disease (CKD) is a growing global health concern, affecting over 700 million people worldwide. Its asymptomatic progression often results in late-stage diagnosis and irreversible kidney damage, particularly in populations with limited access to care. The increasing prevalence of risk factors such as diabetes and hypertension, combined with inadequate risk stratification, contributes to delayed intervention, high mortality, and substantial economic burden. Accurate risk stratification is critical to enable earlier detection and guide timely, targeted interventions. Effective therapies exist to slow CKD progression and reduce cardiovascular risk, underscoring the importance of early detection and robust risk prediction strategies.
CKD is driven by population growth, aging, and the increasing prevalence of diabetes, heart disease, and hypertension, particularly in developed regions. In high-income countries, 1 in 3 people with diabetes and 1 in 5 with hypertension have CKD.1
CKD is asymptomatic in early stages (G1 and G2), resulting in late diagnosis when irreversible damage has already occurred.2
CKD is a major driver of cardiovascular deaths and healthcare costs, yet remains under prioritized in public health strategies.1
Kidney Klinrisk Algorithm is a semi-quantitative in vitro diagnostic device intended as an aid in assessing the risk for progression of an individual patient to suffer significant decline in kidney function and/or to reach end stage kidney disease within a period of up to 5 years. It is intended for adult CKD patients in stages G1 to G4, and to diabetic and/or hypertensive patients that are at risk for CKD.
The Kidney Klinrisk Algorithm is an AI-powered, nonadaptive (locked) machine learning model. It is the first IVDR certified algorithm with a CE mark in the CKD space that can be utilized for early stages of CKD and for patients at risk of developing CKD, such as those with diabetes or hypertension.
The Kidney Klinrisk Algorithm uses only 8 demographic and standard lab parameters (age, sex at birth, eGFR, urine ACR, blood urea nitrogen, random glucose, hemoglobin, and hematocrit).
The Kidney Klinrisk Algorithm can be applied at early stages of CKD and in patients at risk for CKD (e.g. diabetic or hypertensive patients) enabling early treatment interventions.
KDIGO 2024 guidelines mentions that accurate, externally validated risk prediction equations developed for predicting 40% decline in eGFR or kidney failure at all stages of CKD should be used to forecast disease progression in people with early CKD.3
The Kidney Klinrisk Algorithm provides two results, a Klinrisk score estimating the absolute risk for kidney function decline, and the associated risk category: low (green), moderate (yellow), or high (red).
Early intervention can be transformative for patients at risk for kidney function decline. The Roche Kidney Klinrisk Algorithm combines accurate risk stratification with actionable clinical decision support to allow providers to find, triage and treat kidney disease before it progresses. It opens up a new era of proactive and personalized kidney care.
Benefits
The Kidney Klinrisk Algorithm could provide substantial benefits that improve patient care and clinical decision-making. Here are four key advantages illustrating how the algorithm may support individualized patient risk assessment, enable early detection of at-risk patients, enhance risk-based CKD management and support referral decisions.
Early identification of patients at risk for kidney function decline enables timely treatment interventions, potentially delaying CKD onset, slowing its progression and reducing cardiovascular risk.
Aims to reduce unnecessary referrals while ensuring high risk cases reach specialists already early in disease development.
Aims to empower qualified healthcare professionals to make informed management decisions that benefit each individual patient.
Aims to support physicians in communicating the risk and recommended actions, aiming for higher adherence.
The Kidney Klinrisk Algorithm results are provided in the form of a laboratory report that offers a comprehensive summary of essential clinical information.It includes an organized overview of patient data and laboratory results, the Klinrisk score, and its corresponding category. The report also offers personalized clinical decision support, encompassing CKD classification, monitoring frequency, presence of CKD complications, blood pressure targets, and treatment options based on the patient’s laboratory data and clinical guidelines. This supports clinicians in delivering personalized care and making informed decisions.
Experience a single integrated platform designed for healthcare providers and laboratories that simplifies IT complexity while reducing the risk of vulnerabilities. With integrated Roche and partner medical algorithms, we provide a comprehensive solution that streamlines processes and enhances collaboration.
Roche offers centralized customer support for all algorithms in our portfolio to ensure consistency and reliability. We manage issues that arise for all hosted algorithms, streamlining the process and eliminating the need for customers to engage with individual providers.
Security and data privacy are central to Roche’s operations, founded on a “Security and Privacy by Design” philosophy and ISO/IEC 27001 certification. Our dedicated technical team performs ongoing risk assessments, penetration tests, and network monitoring to minimize IT complexity and vulnerabilities, prioritizing data confidentiality to protect patient information across all partners.
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