Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-027-CNI)

Study Overview
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Brief Summary
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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.

Official Title
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Characterisation of Patient Profile and Contemporary Treatment of Pre-dialytic Chronic Kidney Disease (CKD) in Patients Receiving a Restricted Protein Diet Supplemented With Ketosteril® - a Drug Utilisation Study (DUS)

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: Observational study: Supplemented protein-restricted diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic kidney disease (pre-dialysis)<br>Observational study: Supplemented protein-restricted diet | Other: Observational study: Supplemented protein-restricted diet<br>* Observational study: Supplemented protein-restricted diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient compliance to diet (protein and energy intake; investigator and patient-reported, based on patient diary and 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. | Monthly, starting 1 month after enrolment, for a total of 12 months | 
| CKD stage (according to KDIGO guideline) |  | At baseline and 3, 6, 9 and 12 months after enrolment | 
| Presence of comorbidities |  | At baseline | 
| 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 GFR [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 | 
| Haemoglobin A1c [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 [PTH] |  | At baseline and 3, 6, 9 and 12 months after enrolment | 
| Body weight |  | 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 | 
| 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 [BMI] |  | 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 | 
| Worsening of CKD stage |  | 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 | 
| Presence of a 50% reduction in eGFR |  | At baseline and 3, 6, 9 and 12 months after enrolment | 
| Serum bicarbonate |  | At baseline and 3, 6, 9 and 12 months after enrolment | 
| Serum haemoglobin |  | At baseline and 3, 6, 9 and 12 months after enrolment | 
| Serum potassium |  | 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 | 
| Presence of concomitant disease |  | 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 | 
| 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 | 
| Change of food intake 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 | 
| Blood pressure |  | At baseline and 3, 6, 9 and 12 months after enrolment | 
| Heart rate |  | At baseline and 3, 6, 9 and 12 months after enrolment | 
| Body temperature |  | At baseline and 3, 6, 9 and 12 months after enrolment |