L-lysine acetate; L-tryptophan; L-histidine; L-threonine; L-tyrosine; keto-isoleucine calcium; keto-leucine calcium; keto-valine calcium; hydroxi-methionine calcium; alpha-ketophenylalanine calcium for Protein-energy wasting in nephrotic syndrome

Inclusion criteria

• {"criterion_text":"- Nephrotic syndrome defined as a 24-hour proteinuria greater than 3.5 g (or greater than 50 mg/kg), or a urine protein-to-creatinine ratio (uPCR) greater than 3500 mg/g, and a serum albumin concentration less than or equal to 3.5 g/dL.\n- Glomerular filtration rate equal to or higher than 30 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) equation\n- Age minimum 18 years."}

Exclusion criteria

• {"criterion_text":"- Body mass index (BMI) equal to or greater than 40 kg/m2.\n- Uncontrolled diabetes defined as glycated hemoglobin (HbA1c) level greater than 8% (applicable only to patients with diabetes).\n- Pregnancy.\n- Contraindications to treatment with the preparation of exogenous α-ketoanalogues amino acids.\n- Any disease or condition of the patient that may, in the Investigator's opinion, interfere with the interpretation of the results or with the treatment provided in the clinical trial or otherwise prevent participation in the clinical trial and compliance with the requirements of the study protocol.\n- Addiction to alcohol, psychoactive substances or psychotropic drugs within 1 year prior to the screening visit.\n- Participation in another clinical trial with an unauthorised investigational medicinal product within 6 months preceding the screening visit.\n- Elapsed time less than 5 half-life periods since the last administration an investigational medicinal product in another clinical trial, on the date of randomization of the patient (visit 1)."}

Primary endpoints

• {"endpoint_text":"- Change in lean body mass from baseline within 6 weeks after enrollment in the study (non-inferiority).","definition_or_measurement_approach":"Change in lean body mass measured from baseline to 6 weeks after enrollment; non-inferiority analysis."}

Secondary endpoints

• {"endpoint_text":"- Change in lean body mass from baseline within 6 weeks after enrollment in the study (superiority).","definition_or_measurement_approach":"Change in lean body mass measured from baseline to 6 weeks after enrollment; superiority analysis."}
• {"endpoint_text":"- Change in handgrip strength value of the dominant handwithin 6 weeks after enrollment in the study.","definition_or_measurement_approach":"Change in handgrip strength of the dominant hand measured from baseline to 6 weeks."}
• {"endpoint_text":"- Change from baseline in serum albumin concentration at Week 6.","definition_or_measurement_approach":"Serum albumin concentration change from baseline to Week 6."}
• {"endpoint_text":"- Change from baseline in urine protein-to-creatinine ratio (uPCR) at Week 6.","definition_or_measurement_approach":"uPCR change from baseline to Week 6."}
• {"endpoint_text":"- Change from baseline in serum low-density lipoprotein (LDL) concentration at Week 6.","definition_or_measurement_approach":"Serum LDL concentration change from baseline to Week 6."}
• {"endpoint_text":"- Change from baseline in serum triglyceride concentration at Week 6.","definition_or_measurement_approach":"Serum triglyceride concentration change from baseline to Week 6."}
• {"endpoint_text":"- Change from baseline in serum uric acid concentration at Week 6.","definition_or_measurement_approach":"Serum uric acid concentration change from baseline to Week 6."}
• {"endpoint_text":"- Safety assessment including the analysis of adverse events (according to CTCAE and MedDRA), evaluation of the relationship between adverse events and the investigational medicinal product, and analysis of selected laboratory parameters during the treatment period, the mandatory follow-up period, and the observation period.","definition_or_measurement_approach":"Safety assessed by analysis of adverse events coded per CTCAE and MedDRA, investigator assessment of relationship to IMP, and selected laboratory parameter analysis across treatment, follow-up and observation periods."}

Poland

Earliest CTIS Part Ii Submission Date

21-10-2024

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

520

Number Of Sites

8

Number Of Participants

150

Primary sponsor

Full Name

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland