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.
Study Type
OBSERVATIONAL
Enrollment
164
Observational study: Supplemented protein-restricted diet
Velencei-tavi Kistérségi Járóbeteg Szakellátó Közhasznú Nonprofit Kft
Velence, Hungary
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.
Time frame: Daily, for a total of 12 months
Patient compliance to diet (protein and energy intake, based on a routine 3-day food diary)
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.
Time frame: Monthly starting 1 month after enrolment, for a total of 12 months
CKD stage (according to KDIGO guideline)
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Presence of comorbidities
e.g., diabetes, hypertension, metabolic syndrome
Time frame: At baseline
Serum creatinine
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
24h urinary protein
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Urinary microalbumin
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
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Serum urea
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Creatinine clearance
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Glomerular filtration rate (GFR)
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Estimated glomerular filtration rate (eGFR)
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Fasting blood glucose
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Fasting plasma glucose
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
HbA1c
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum triglyceride
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum cholesterol
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum high-density lipoprotein (HDL)
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum low-density lipoprotein (LDL)
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum calcium
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum phosphate
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum parathyroid hormone
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Weight
Total body weight
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Skinfold thickness
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum total protein
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum albumin
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum prealbumin
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Body mass index
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Subjective Global Assessment
Final result/score to be reported
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Decline in eGFR
Time frame: At 3, 6, 9 and 12 months after enrolment
Worsening of CKD stage
Time frame: At 3, 6, 9 and 12 months after enrolment
Start of dialysis
Time frame: At 3, 6, 9 and 12 months after enrolment
Presence of a 50% reduction in eGFR
Time frame: At 3, 6, 9 and 12 months after enrolment
Serum bicarbonate
Time frame: At baseline and 3, 6 and 12 months after enrolment
Serum haemoglobin
Time frame: At baseline and 3, 6 and 12 months after enrolment
Serum potassium
Time frame: At baseline and 3, 6 and 12 months after enrolment
Reported nausea and vomiting
Time frame: At baseline and 3, 6 and 12 months after enrolment
Presence of concomitant disease
Time frame: At 3, 6, 9 and 12 months after enrolment
Administration of concomitant medication
Time frame: At 3, 6, 9 and 12 months after enrolment
Discontinuation of diet and Ketosteril with the reasons for discontinuation as reported by the investigator
Time frame: Monthly starting at 1 month after enrolment for up to 12 months
Acceptance of diet as documented in the patient diary
Time frame: Daily for up to 12 months
Appetite change as documented in the patient diary
Time frame: Daily for up to 12 months
Change of food intake as documented in the patient diary
Time frame: Daily for up to 12 months
Adverse events including adverse drug reactions and serious adverse events
Time frame: At 3, 6, 9 and 12 months after enrolment
Blood pressure
Time frame: At baseline and 3, 6, 9 and at 12 months after enrolment
Heart rate
Time frame: At baseline and 3, 6, 9 and at 12 months after enrolment
Body temperature
Time frame: At baseline and 3, 6, 9 and at 12 months after enrolment