Forma
Project data
Project financing: 9 605 089,78 PLN (including financing for UMED: 715 419,18 PLN), financed by the Medical Research Agency (ABM)
Project description:
FORMA is a phase III multicenter clinical trial investigating the efficacy and safety of the use of an essential amino acid ketoanalogue (Ketosteril) as an add-on therapy to reduce muscle mass loss in patients with nephrotic syndrome.
Nephrotic syndrome is a rare clinical syndrome that develops in the course of various glomerular diseases. The annual incidence is estimated at 17 per million people. Diagnosis and treatment of nephrotic syndrome and its complications are an important challenge for modern nephrology. Nephrotic syndrome is characterized by massive proteinuria (>3.5 g/day), hypoalbuminemia, hyperlipidemia, and edema. It leads to a number of complications, including increased muscle catabolism and progressive cachexia. So far, no optimal intervention has been developed to limit this effect.
The FORMA trial will evaluate the effectiveness of adding Ketosteril to a standard therapy to prevent muscle loss. In addition, patients will be under the constant care of a dietitian. It is planned to include 150 patients with nephrotic syndrome, who will be randomly assigned to the group receiving Ketosteril or the control group receiving nutritional therapy only. The study does not interfere with the basic (immunosuppressive) treatment of the underlying disease that led to the development of nephrotic syndrome.
As part of the study, it is also planned to conduct a number of additional analyzes that will serve to expand knowledge about the disease, genetic predispositions to its development, as well as changes in the metabolic and hormonal profile that occur in the course of the disease. The first bank of genomic data and biological samples in Poland will be created for further in-depth basic research in patients with nephrotic syndrome.
Beneficiary
Consortium composed of:
Military Medical Institute – National Research Institute (Leader),
Medical University of Lodz (Partner).
Coordinating Principal Investigator
prof. Stanislaw Niemczyk, MD, PhD
Department of Internal Diseases, Nephrology and Dialysis,
Military Medical Institute – National Research Institute
UMED Site Principal Investigator
prof. Ilona Kurnatowska, MD, PhD