💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Ketosteril
- Medium Protein Diet (MPD)
Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research Institute
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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