Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome

Recruiting Phase 3 Interventional Study
Nephrotic Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
150 (estimated)
Sponsor
Military Institute od Medicine National Research Institute · Other
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About This Trial

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.

Trial Locations
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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…
Contacts

Anna Matyjek, MD, PhD

261817045

amatyjek@wim.mil.pl

CONTACT