Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)

Fresenius Kabi154 enrolled

Overview

The purpose of this study is to characterize 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.

Study Type

OBSERVATIONAL

Enrollment

154

Conditions

Chronic Kidney Disease

Interventions

Observational study: Supplemented protein-restricted dietOTHER

Observational study: Supplemented protein-restricted diet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * written informed consent * non-dialyzed patients with CKD * indication for Ketosteril according to package insert (PI), 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

Locations (1)

Prof. Xiangmei

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Patient compliance to Ketosteril (number of tablets taken; patient reported)

This is an observational study aiming to characterise the patient profile and contemporary treatment of pre-dialytic chronic kidney disease (CKD) in patients receiving a restricted protein diet supplemented with Ketosteril®. There is no distinction between primary and secondary outcome measures in the observational plan, and only Routine procedures are documented. Patient compliance to Ketosteril will be assessed daily, for a total of 12 months.

Time frame: 12 months

Secondary Outcomes

Patient compliance to diet (protein and energy intake; investigator and patient-reported, based on patient diary and a routine 3-day food diary)

Time frame: Monthly, starting 1 month after enrolment, for a total of 12 months

CKD stage (according to Kidney Disease Improving Global Outcomes [KDIGO] guideline)