Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome
NCT ID: NCT05716880
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2023-01-03
2027-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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KA+MPD
Ketosteril + Medium Protein Diet (MPD) for 12 months
Ketosteril
Daily dose = 1 tabl / 5 kg of ideal body weight
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
MPD
Medium Protein Diet (MPD) for 12 months
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
Interventions
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Ketosteril
Daily dose = 1 tabl / 5 kg of ideal body weight
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Medical University of Lodz
OTHER
Medical University of Warsaw
OTHER
Military Institute od Medicine National Research Institute
OTHER
Responsible Party
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Principal Investigators
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Anna Matyjek
Role: STUDY_CHAIR
Military Institute of Medicine National Research Institute
Locations
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Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research Institute
Warsaw, Masovian District, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2022-000529-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2021/ABM/01/00036-00
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ABM/FORMA/2021
Identifier Type: -
Identifier Source: org_study_id
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