Actively Recruiting
Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome
Led by Military Institute od Medicine National Research Institute · Updated on 2023-02-08
150
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
Sponsors
M
Military Institute od Medicine National Research Institute
Lead Sponsor
M
Medical University of Lodz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Nephrotic syndrome with serum albumin less than 3.0 g/dL and daily proteinuria greater than 3.5 g/day or more than 50 mg/kg
- New diagnosis or relapse of nephrotic syndrome with proteinuria less than 2.0 g/day or uPCR less than 2000 mg/g in the last 6 months prior to relapse and prednisone dose 10 mg/day or less in the last 3 months prior to relapse
- Glomerular filtration rate equal to or higher than 30 mL/min/1.73m2 based on CKD-EPI equation
You will not qualify if you...
- Diabetic kidney disease
- Small vessel vasculitis
- Systemic lupus erythematosus
- Positive antinuclear antibodies, anti-dsDNA, or antineutrophil cytoplasmic antibodies (ANCA)
- Positive anti-HIV or anti-hepatitis C antibodies, HBsAg
- HbA1c greater than 7%
- Monoclonal gammopathy
- Pregnancy
- Body mass index 40 kg/m2 or higher
- Severe acute or chronic disease affecting nutritional status
- Neoplasm
- Contraindication to Ketosteril
- Alcohol or drug abuse
- Mental disorders
- Failure to comply with medical recommendations or lack of cooperation
- Participation in other clinical trials or use of Ketosteril within the past year prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research Institute
Warsaw, Masovian District, Poland, 04-141
Actively Recruiting
Research Team
A
Anna Matyjek, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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