Observational Study on Chronic Kidney Disease Treatment With a Ketosteril Supplemented Protein-restricted Diet

Fresenius Kabi

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Other: Observational study: Supplemented protein-restricted diet

Study type: Observational

Funder types: Industry

Identifiers

NCT02649205

Keto-023-CNI

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

164 participants in 1 patient group

Chronic kidney disease (pre-dialysis)

Description:

Observational study: Supplemented protein-restricted diet

Treatment:

Other: Observational study: Supplemented protein-restricted diet