Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-027-CNI)
- Conditions
- Chronic Kidney Disease
- Registration Number
- NCT02746133
- Lead Sponsor
- Fresenius Kabi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient compliance to Ketosteril (number of tablets taken; patient reported) 12 months 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.
- Secondary Outcome Measures
Name Time Method Estimated GFR [eGFR] At baseline and 3, 6, 9 and 12 months after enrolment Serum creatinine At baseline and 3, 6, 9 and 12 months after enrolment Patient compliance to diet (protein and energy intake; investigator and patient-reported, based on patient diary and a routine 3-day food diary) Monthly, starting 1 month after enrolment, for a total of 12 months 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.
CKD stage (according to KDIGO guideline) At baseline and 3, 6, 9 and 12 months after enrolment Presence of comorbidities At baseline 24h urinary protein At baseline and 3, 6, 9 and 12 months after enrolment Urinary microalbumin At baseline and 3, 6, 9 and 12 months after enrolment Creatinine clearance At baseline and 3, 6, 9 and 12 months after enrolment Glomerular filtration rate (GFR) At baseline and 3, 6, 9 and 12 months after enrolment Haemoglobin A1c [HbA1c] At baseline and 3, 6, 9 and 12 months after enrolment Serum low-density lipoprotein [LDL] At baseline and 3, 6, 9 and 12 months after enrolment Serum triglyceride At baseline and 3, 6, 9 and 12 months after enrolment Serum calcium At baseline and 3, 6, 9 and 12 months after enrolment Body weight At baseline and 3, 6, 9 and 12 months after enrolment Worsening of CKD stage At baseline and 3, 6, 9 and 12 months after enrolment Fasting blood glucose At baseline and 3, 6, 9 and 12 months after enrolment Serum cholesterol At baseline and 3, 6, 9 and 12 months after enrolment Serum prealbumin At baseline and 3, 6, 9 and 12 months after enrolment Body mass index [BMI] At baseline and 3, 6, 9 and 12 months after enrolment Start of dialysis At baseline and 3, 6, 9 and 12 months after enrolment Serum potassium At baseline and 3, 6, 9 and 12 months after enrolment Fasting plasma glucose At baseline and 3, 6, 9 and 12 months after enrolment Serum albumin At baseline and 3, 6, 9 and 12 months after enrolment Serum bicarbonate At baseline and 3, 6, 9 and 12 months after enrolment Administration of concomitant medication At baseline and 3, 6, 9 and 12 months after enrolment Change of food intake as documented in the patient diary Daily, for up to 12 months Heart rate At baseline and 3, 6, 9 and 12 months after enrolment Skinfold thickness At baseline and 3, 6, 9 and 12 months after enrolment Serum total protein At baseline and 3, 6, 9 and 12 months after enrolment Subjective global assessment [SGA] At baseline and 3, 6, 9 and 12 months after enrolment Decline in eGFR At baseline and 3, 6, 9 and 12 months after enrolment Presence of a 50% reduction in eGFR At baseline and 3, 6, 9 and 12 months after enrolment Serum haemoglobin At baseline and 3, 6, 9 and 12 months after enrolment Reported nausea and vomiting At baseline and 3, 6, 9 and 12 months after enrolment Appetite change as documented in the patient diary Daily, for up to 12 months Blood pressure At baseline and 3, 6, 9 and 12 months after enrolment Presence of concomitant disease At baseline and 3, 6, 9 and 12 months after enrolment Discontinuation of diet and Ketosteril with the reasons for discontinuation as reported by the investigator Monthly, starting at 1 month after enrolment for up to 12 months Acceptance of diet as documented in the patient diary Daily, for up to 12 months Adverse events including adverse drug reactions and serious adverse events At baseline and 3, 6, 9 and 12 months after enrolment Body temperature At baseline and 3, 6, 9 and 12 months after enrolment Serum urea At baseline and 3, 6, 9 and 12 months after enrolment Serum high-density lipoprotein [HDL] At baseline and 3, 6, 9 and 12 months after enrolment Serum phosphate At baseline and 3, 6, 9 and 12 months after enrolment Serum parathyroid hormone [PTH] At baseline and 3, 6, 9 and 12 months after enrolment