Health TrialsbyHealthPanel

Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome

ConditionNephrotic Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilitary Institute od Medicine National Research Institute

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 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.

Disqualifiers

Diabetic kidney disease;

Small vessels vasculitis;

Systemic lupus erythematosus;

Positive antinuclear antibodies, anti-dsDNA or antineutrophil cytoplasmic antibodies (ANCA);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketosteril

    Drug

    Daily dose = 1 tabl / 5 kg of ideal body weight

  • Medium Protein Diet (MPD)

    Other intervention

    MPD: daily protein intake of 0.8-1.0 g/kg of ideal body weight + up to 5 g based on daily proteinuria

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: KA+MPDExperimental treatment 2 interventions
Group B: MPDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximum loss of lean tissue mass

The difference between the initial lean tissue mass (LTM) and the lowest LTM measured within 6 months, expressed in percentage. The non-inferiority hypothesis of Ketosteril use will be tested as the primary endpoint. LTM will be measured with bioimpedance spectroscopy.

Time frame
6 months

Secondary outcomes

1

Maximum loss of lean tissue mass

The difference between the initial lean tissue mass (LTM) and the lowest LTM measured within 6 months, expressed in percentage. The superiority hypothesis of Ketosteril use will be tested as the secondary endpoint.

Time frame
6 months
2

Neph-PEW diagnosis

The percentage of patients meeting criteria of nephrotic syndrome-associated protein-energy wasting (neph-PEW): reduction of LTM by 3% within 3 months or by 5% within 6 months.

Time frame
6 months
3

6-minute walk test distance

Change in distance walked in the 6-minute walk test from baseline value; expressed in meters.

Time frame
6 months
4

Handgrip strength (HGS)

Change in HGS value from baseline; expressed in kg.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Military Institute od Medicine National Research Institute

Lead sponsor

Medical University of Lodz

Collaborator

Medical University of Warsaw

Collaborator

Source ClinicalTrials.gov
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