Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome
ConditionNephrotic Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilitary Institute od Medicine National Research Institute
About this trial
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
Qualifiers
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.
Disqualifiers
Diabetic kidney disease;
Small vessels vasculitis;
Systemic lupus erythematosus;
Positive antinuclear antibodies, anti-dsDNA or antineutrophil cytoplasmic antibodies (ANCA);
Trial design
Treatments tested in this trial
- Ketosteril
- Medium Protein Diet (MPD)
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
1Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research Institute04-141, WarsawMasovian District, Poland
Sponsors and collaborators
Military Institute od Medicine National Research Institute
Lead sponsor
Medical University of Lodz
Collaborator
Medical University of Warsaw
Collaborator
Source ClinicalTrials.gov