Using ketoanalogues to prevent muscle 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

This study is testing if adding a special supplement called ketoanalogues to a medium protein diet can help adults with nephrotic syndrome keep their muscle mass and function.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Military Institute od Medicine National Research Institute (Academic / other)
• Locations: 1 site (Warsaw, Masovian District)
• Trial ID: NCT05716880 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults with nephrotic syndrome who have a serum albumin level below 3.0 g/dL and a glomerular filtration rate of at least 30 mL/min/1.73m2.

Not a fit: Patients with diabetic kidney disease, severe obesity, or other severe diseases affecting nutritional status may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help preserve muscle mass and improve nutritional status in patients with nephrotic syndrome.

How similar studies have performed: While the use of ketoanalogues in this context is relatively novel, similar approaches in managing protein-energy wasting have shown promise in other studies.

Eligibility criteria

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 this trial is running

Warsaw, Masovian District

• 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

Conditions Nephrotic Syndrome; nephrotic syndrome; protein-energy wasting; neph-PEW; lean tissue mass; Ketosteril; ketoanalogues