Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome (FORMA)
Nephrotic Syndrome
About this trial
This is an interventional supportive care trial for Nephrotic Syndrome focused on measuring nephrotic syndrome, protein-energy wasting, neph-PEW, lean tissue mass, Ketosteril, ketoanalogues
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 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.
Sites / Locations
- Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
KA+MPD
MPD
Ketosteril + Medium Protein Diet (MPD) for 12 months
Medium Protein Diet (MPD) for 12 months