Using ketoanalogues to prevent muscle loss in nephrotic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of ketoanalogues of essential amino acids in preventing protein-energy wasting in patients with nephrotic syndrome. Adult participants with a new diagnosis or relapse of nephrotic syndrome will be randomly assigned to receive either Ketosteril as an add-on to a medium protein diet or just the diet alone. The study will assess the preservation of lean tissue mass over six months, alongside muscle function and laboratory indicators of catabolism. Participants will also receive treatment for their underlying glomerular disease as per current guidelines.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research Institute
  Warsaw, Masovian District, Poland Recruiting

Study contacts

• Study coordinator: Anna Matyjek, MD, PhD
• Email: amatyjek@wim.mil.pl
• Phone: 261817045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Smartphone app to help follow the 2024 KDIGO chronic kidney disease guidelines

  This project will test whether a smartphone app helps young adults (ages 16–29) with chronic kidney disease follow the 2024 KDIGO guideline recommendations.

  Recruiting at 2 sites St. James's Hospital, Ireland · Dublin and 1 other locations · NCT07561957

• SGLT2 inhibitors added to standard care in adult primary nephrotic syndrome

  This trial tests whether adding dapagliflozin or empagliflozin to standard treatment helps reduce protein in urine for adults with primary nephrotic syndrome.

  Recruiting Phase 2/3 Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07214818

• Atacicept for multiple autoimmune glomerular diseases

  This will test whether weekly injections of atacicept can lower protein in the urine and help preserve kidney function in people aged 10 and older with IgA nephropathy, primary membranous nephropathy, or nephrotic syndromes such as MCD and FSGS.

  Recruiting Phase 2 Vera Therapeutics, Inc. · Brisbane, California · NCT06983028

• Multitarget approach for primary podocytopathies

  This project will test whether a lab cell culture can find a factor in the blood that causes proteinuria in people with primary podocytopathies and whether a combined therapy can block that factor in vitro.

  Recruiting at 2 sites Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan and 1 other locations · NCT06718894

• Follow-up on Rituximab treatment for children's nephrotic syndrome

  This study looks at how well rituximab works and its safety for children with hard-to-treat nephrotic syndrome by reviewing their past treatment data.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT06530004

• Investigating the role of a protein in kidney damage related to nephrotic syndrome

  This study is trying to see if a protein called PCSK9 is linked to kidney damage and high cholesterol in people with nephrotic syndrome.

  Recruiting Kolding Sygehus · Kolding · NCT06373913

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.