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Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome

NCT05716880 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-02-08

No results posted yet for this study

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.

Conditions

  • Nephrotic Syndrome

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

Sponsors & Collaborators

  • Medical University of Lodz

    collaborator OTHER

  • Medical University of Warsaw

    collaborator OTHER

  • Military Institute od Medicine National Research Institute

    lead OTHER

Principal Investigators

  • Anna Matyjek · Military Institute of Medicine National Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2027-02-28
Completion
2027-08-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05716880 on ClinicalTrials.gov