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RECRUITING
NCT05716880
PHASE3

Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome

Sponsor: Military Institute od Medicine National Research Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-01-03

Completion Date

2027-08-31

Last Updated

2023-02-08

Healthy Volunteers

No

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

Locations (1)

Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research Institute

Warsaw, Masovian District, Poland