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
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Poland
Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research Institute
RECRUITING
Warsaw
Contact Information
Primary
Anna Matyjek, MD, PhD
amatyjek@wim.mil.pl
261817045
Time Frame
Start Date: 2023-01-03
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 150
Treatments
Experimental: KA+MPD
Ketosteril + Medium Protein Diet (MPD) for 12 months
Active_comparator: MPD
Medium Protein Diet (MPD) for 12 months
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of Lodz, Medical University of Warsaw
Leads: Military Institute od Medicine National Research Institute