Short-term Metabolic Effects of Ketosteril® Supplemented Low Protein Diet in Pre-dialysis Chronic Kidney Disease (CKD) Patients

Inclusion criteria

• Written informed consent
• Non-dialysed male and female CKD patients with expected start of dialysis ≥ 3 months
• eGFR ≥5 to < 30 ml/min/1.73 m2
• Stable renal function at least 12 weeks before enrollment, defined by change in serum creatinine ≤ 80 µmol/L
• Body mass index (BMI): ≥ 22 kg/m² and ≤ 35 kg/m2
• Age: ≥ 40 to ≤ 75 years
• Eligible physical status of the patient for participation in the study upon assessment of the investigator based on medical history, physical examination and clinical laboratory parameters

Exclusion criteria

• Existing gastrointestinal diseases or pathological findings (e.g. heart, liver, or lung failure), which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient (e.g. persistent or frequent episodes of anorexia, vomiting, or diarrhea)
• Active cancer
• Diabetes treated with standard pharmacotherapy
• HbA1c ≥ 48 mmol/mol, and/or fasting blood glucose ≥ 126 mg/dl (≥ 7 mmol/L))
• Evidence of chronic infection or chronic inflammation; evidence of acute infection or acute inflammation
• C-reactive protein (CRP) > 20 mg/L determined at screening examination
• Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparation
• Severe allergies or multiple drug allergies if judged as relevant for the clinical trial by the investigator
• Patients suffering from hypercalcaemia with a serum calcium ≥ 2.9 mmol/L performed on screening examination
• Major disorder of amino acid metabolism, e.g. hereditary diseases
• Hospitalization within the previous 1 month
• Proteinuria > 3 g/day
• Regular intensive exercise
• Ingestion of creatine supplements within the previous 1 month
• Intake of other anabolic or anti catabolic agents within the previous 1 month
• Any change of the chronic medication within 1 month before screening
• Autosomal dominant polycystic kidney disease (ADPKD)
• Positive anti-HIV-test (if positive to be verified by western blot), Hepatitis B surface antigen (HBsAG)-test (if positive to be verified by test for hepatitis B core antigen (HBc)- Immunoglobulin M (IgM)) or anti-hepatitis C virus (HCV)-test
• Current drug or alcohol dependence
• Blood donation (including donation of plasma and platelets) or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the patient
• Participation in an interventional clinical trial during the last 2 months prior to individual enrolment of the patient
• Patients who report a frequent occurrence of migraine attacks (i.e. at least once per month)
• History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
• Change in habits of physical activity within the last 2 months for at least 7 days (e.g. immobilisation due to bed rest, immobilisation of a leg or other big muscle groups)
• Positive pregnancy test at screening examination
• Pregnant or lactating women
• Not willing to apply highly effective contraceptive methods [i.e. combined (estrogen and progestogen containing) hormonal contraception e.g. oral, intravaginal, transdermal and progestogen-only hormonal contraception e.g. oral, injectable, implantable as well as intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) in combination with male condom; bilateral tubal occlusion, vasectomised partner or sexual abstinence]
• Patients suspected or known not to follow instructions
• Patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial