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New treatment option for Nephrotic Syndrome
Official title Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome
ClinicalTrials.gov ID: NCT05716880
What this study is testing
What is Ketosteril?
Ketosteril is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for nephrotic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Nephrotic syndrome with serum albumin \ 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...
- Glomerular filtration rate qual to or higher than 30 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
You likely can't join if
- 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%;
See the full eligibility criteria
- Nephrotic syndrome with serum albumin \ 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...
- Glomerular filtration rate qual to or higher than 30 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian District, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian District, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.