Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome

• Status: Recruiting
• Trial end date: 2027-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Military Institute of Medicine, Poland
• Collaborators: Medical University of Lodz; Medical University of Warsaw

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.