Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketosteril, Medium Protein Diet (MPD).
- Who it may be relevant to
- Registry conditions: Nephrotic Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
Adult patients with new diagnosis or relapse of nephrotic syndrome and glomerular filtration rate of ≥ 30 mL/min/1.73m2 will be included in the study. Exclusion criteria will be a secondary cause of nephrotic syndrome, morbid obesity and severe diseases affecting nutritional status.
Participants will be randomly assigned to the intervention group (KA+MPD) or control group (MPD); randomization will be stratified by type of glomerular disease (podocytopathy or other type) and investigational site. The control group will follow the diet recommended in nephrotic syndrome - a medium protein diet (MPD) - under the care of a dietitian. Intervention group will receive Ketosteril (1 tablet for every 5 kg of ideal body weight) as an addition to the diet. All patients will also receive treatment for underlying glomerular disease in accordance with current guidelines and local practice.
The main objective is to assess the efficacy of Ketosteril as an add-on therapy in preventing the loss of lean tissue mass (LTM) over 6 months compared to a standard diet.
The additional aims include the assessment of muscle function parameters, nephrotic syndrome severity and laboratory indicators of catabolism.
Interventions
- Drug Ketosteril
Daily dose = 1 tabl / 5 kg of ideal body weight - Other Medium Protein Diet (MPD)
MPD: daily protein intake of 0.8-1.0 g/kg of ideal body weight + up to 5 g based on daily proteinuria
Primary outcome measures
- Maximum loss of lean tissue mass [Time frame: 6 months]
Secondary outcome measures (11)
- Maximum loss of lean tissue mass [Time frame: 6 months]
- Neph-PEW diagnosis [Time frame: 6 months]
- 6-minute walk test distance [Time frame: 6 months]
- Handgrip strength (HGS) [Time frame: 6 months]
- Serum albumin [Time frame: 6 months]
- Urinary protein/creatinine ratio (uPCR) [Time frame: 6 months]
- Low density lipoprotein (LDL) [Time frame: 6 months]
- Triglycerides [Time frame: 6 months]
- Uric acid [Time frame: 6 months]
- Unfavorable disease course [Time frame: 12 months]
- Glomerular filtration rate [Time frame: 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Poland · 1 center
- Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - — Warsaw
Publications
- Matyjek A, Literacki S, Niemczyk S, Rymarz A. Protein energy-wasting associated with nephrotic syndrome - the comparison of metabolic pattern in severe nephrosis to different stages of chronic kidney disease. BMC Nephrol. 2020 Aug 14;21(1):346. doi: 10.1186/s12882-020-02003-4. PMID 32795277
- Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. No abstract available. PMID 34556256
- Fouque D, Kalantar-Zadeh K, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H, Guarnieri G, Ikizler TA, Kaysen G, Lindholm B, Massy Z, Mitch W, Pineda E, Stenvinkel P, Trevino-Becerra A, Wanner C. A proposed nomenclature and diagnostic criteria for protein-energy wasting in acute and chronic kidney disease. Kidney Int. 2008 Feb;73(4):391-8. doi: 10.1038/sj.ki.5002585. Epub 2007 Dec 19. PMID 18094682
- Kaysen GA, Gambertoglio J, Jimenez I, Jones H, Hutchison FN. Effect of dietary protein intake on albumin homeostasis in nephrotic patients. Kidney Int. 1986 Feb;29(2):572-7. doi: 10.1038/ki.1986.36. PMID 3702214
- Barsotti G, Morelli E, Cupisti A, Bertoncini P, Giovannetti S. A special, supplemented 'vegan' diet for nephrotic patients. Am J Nephrol. 1991;11(5):380-5. doi: 10.1159/000168342. PMID 1809035
Identifiers
NCT: NCT05716880 · ABM/FORMA/2021 · 2022-000529-26 · 2021/ABM/01/00036-00