Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome
Trial Parameters
Brief Summary
The goal of this non-commercial clinical trial is to assess efficacy and safety of ketoanalogues of essential amino acids in the prevention of protein-energy wasting in nephrotic syndrome.
Eligibility Criteria
Inclusion Criteria: * Nephrotic syndrome with serum albumin \< 3.0 g/dL and daily proteinuria of \> 3.5 g/day or \> 50 mg/kg; * New diagnosis or relapse of nephrotic syndrome (defined as: proteinuria of \< 2.0 g/day or uPCR \< 2000 mg/g in the last 6 months prior to relapse and prednison dose equal to or less than 10 mg/day in the last 3 months prior relapse); * Glomerular filtration rate qual to or higher than 30 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Exclusion Criteria: * Diabetic kidney disease; * Small vessels vasculitis; * Systemic lupus erythematosus; * Positive antinuclear antibodies, anti-dsDNA or antineutrophil cytoplasmic antibodies (ANCA); * Positive anti-HIV or anti-hepatitis C antibodies, HBsAg; * HbA1c \>7%; * Monoclonal gammopathy; * Pregnancy; * Body mass index \>= 40 kg/m2; * Severe acute or chronic disease affecting nutritional status; * Neoplasm; * Contraindication to Ketosteril; * Alcohol or drug abuse; * Mental