Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome

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.

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 disorders;Failure to comply with medical recommendations, lack of cooperation;Participation in other clinical trial or the use of Ketosteril in the last 1 year prior to screening.