Chronic Kidney Disease
Conditions
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.
Interventions
Observational study: Supplemented protein-restricted diet
Sponsors
Fresenius Kabi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient compliance to Ketosteril (number of tablets taken; patient-reported) | Daily, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CKD stage (according to KDIGO guideline) | At baseline and 3, 6, 9 and 12 months after enrolment | — |
| Presence of comorbidities | At baseline | e.g., diabetes, hypertension, metabolic syndrome |
| Serum creatinine | At baseline and 3, 6, 9 and 12 months after enrolment | — |
| 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 | — |
| Serum urea | 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 | — |
| Estimated glomerular filtration rate (eGFR) | 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 | — |
| Fasting plasma glucose | At baseline and 3, 6, 9 and 12 months after enrolment | — |
| HbA1c | 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 cholesterol | 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 low-density lipoprotein (LDL) | At baseline and 3, 6, 9 and 12 months after enrolment | — |
| Serum calcium | 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 | At baseline and 3, 6, 9 and 12 months after enrolment | — |
| Weight | At baseline and 3, 6, 9 and 12 months after enrolment | Total body weight |
| 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 | — |
| Serum albumin | 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 | At baseline and 3, 6, 9 and 12 months after enrolment | — |
| Subjective Global Assessment | At baseline and 3, 6, 9 and 12 months after enrolment | Final result/score to be reported |
| Decline in eGFR | At 3, 6, 9 and 12 months after enrolment | — |
| Worsening of CKD stage | At 3, 6, 9 and 12 months after enrolment | — |
| Start of dialysis | At 3, 6, 9 and 12 months after enrolment | — |
| Presence of a 50% reduction in eGFR | At 3, 6, 9 and 12 months after enrolment | — |
| Serum bicarbonate | At baseline and 3, 6 and 12 months after enrolment | — |
| Serum haemoglobin | At baseline and 3, 6 and 12 months after enrolment | — |
| Serum potassium | At baseline and 3, 6 and 12 months after enrolment | — |
| Reported nausea and vomiting | At baseline and 3, 6 and 12 months after enrolment | — |
| Presence of concomitant disease | At 3, 6, 9 and 12 months after enrolment | — |
| Administration of concomitant medication | At 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 | — |
| Appetite change as documented in the patient diary | Daily for up to 12 months | — |
| Patient compliance to diet (protein and energy intake, based on 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. |
| Adverse events including adverse drug reactions and serious adverse events | At 3, 6, 9 and 12 months after enrolment | — |
| Blood pressure | At baseline and 3, 6, 9 and at 12 months after enrolment | — |
| Heart rate | At baseline and 3, 6, 9 and at 12 months after enrolment | — |
| Body temperature | At baseline and 3, 6, 9 and at 12 months after enrolment | — |
| Change of food intake as documented in the patient diary | Daily for up to 12 months | — |
Countries
Hungary
Outcome results
None listed