Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-027-CNI)

Characterisation of Patient Profile and Contemporary Treatment of Pre-dialytic Chronic Kidney Disease (CKD) in Patients Receiving a Restricted Protein Diet Supplemented With Ketosteril® - a Drug Utilisation Study (DUS)

The purpose of this study is to characterise the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal insufficiency, calcium and phosphorus metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as the persistent dietary education to ensure compliance in a large group of pre-dialysis patients.

Inclusion Criteria:

• written informed consent
• non-dialyzed patients with CKD
• indication for Ketosteril according to Summary of Product Characteristics (SmPC), including a glomerular filtration rate (GFR) < 25 mL/min
• accepted supplemented protein-restricted diet and newly starting with Ketosteril (treatment naïve, i.e., never treated with Ketosteril before)
• adult patients ≥ 18 years

Exclusion Criteria:

• active cancer diseases
• pregnancy or breast feeding
• hypersensitivity to active substances or to any of the excipients in Ketosteril
• hypercalcaemia
• major disorder of amino acid metabolism, e.g., hereditary diseases
• participation in any clinical trial with an investigational drug within 30 days prior to start of study or during the study
• illiteracy or incapability to read or write