Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome
FORMA - a Multicenter Randomized-controlled Trial to Evaluate the Efficacy and Safety of Ketoanalogues of Essential Amino Acids in Prophylaxis of Protein-energy Wasting in Nephrotic Syndrome
Military Institute od Medicine National Research Institute
150 participants
Jan 3, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria16
- 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.
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Interventions
Daily dose = 1 tabl / 5 kg of ideal body weight
MPD: daily protein intake of 0.8-1.0 g/kg of ideal body weight + up to 5 g based on daily proteinuria
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05716880