NCT05716880

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
16mo left

Started Jan 2023

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2023Aug 2027

Study Start

First participant enrolled

January 3, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

4.2 years

First QC Date

January 30, 2023

Last Update Submit

January 30, 2023

Conditions

Nephrotic Syndrome

Keywords

nephrotic syndromeprotein-energy wastingneph-PEWlean tissue massKetosterilketoanalogues

Outcome Measures

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.

    6 months

Secondary Outcomes (11)

  • Maximum loss of lean tissue mass

    6 months

  • Neph-PEW diagnosis

    6 months

  • 6-minute walk test distance

    6 months

  • Handgrip strength (HGS)

    6 months

  • Serum albumin

    6 months

  • +6 more secondary outcomes

Study Arms (2)

KA+MPD

EXPERIMENTAL

Ketosteril + Medium Protein Diet (MPD) for 12 months

Drug: KetosterilOther: Medium Protein Diet (MPD)

MPD

ACTIVE COMPARATOR

Medium Protein Diet (MPD) for 12 months

Other: Medium Protein Diet (MPD)

Interventions

KetosterilDRUG

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

KA+MPD
Medium Protein Diet (MPD)OTHER

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

KA+MPDMPD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Diabetic kidney disease;
  • Small vessels vasculitis;
  • Systemic lupus erythematosus;
  • Positive antinuclear antibodies, anti-dsDNA or antineutrophil cytoplasmic antibodies (ANCA);
  • Positive anti-HIV or anti-hepatitis C antibodies, HBsAg;
  • HbA1c \>7%;
  • Monoclonal gammopathy;
  • Pregnancy;
  • Body mass index \>= 40 kg/m2;
  • Severe acute or chronic disease affecting nutritional status;
  • Neoplasm;
  • Contraindication to Ketosteril;
  • Alcohol or drug abuse;
  • Mental disorders;
  • Failure to comply with medical recommendations, lack of cooperation;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, Masovian District, 04-141, Poland

RECRUITING

Related Publications (5)

  • Matyjek A, Literacki S, Niemczyk S, Rymarz A. Protein energy-wasting associated with nephrotic syndrome - the comparison of metabolic pattern in severe nephrosis to different stages of chronic kidney disease. BMC Nephrol. 2020 Aug 14;21(1):346. doi: 10.1186/s12882-020-02003-4.

    PMID: 32795277BACKGROUND

  • Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. No abstract available.

    PMID: 34556256BACKGROUND

  • Fouque D, Kalantar-Zadeh K, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H, Guarnieri G, Ikizler TA, Kaysen G, Lindholm B, Massy Z, Mitch W, Pineda E, Stenvinkel P, Trevino-Becerra A, Wanner C. A proposed nomenclature and diagnostic criteria for protein-energy wasting in acute and chronic kidney disease. Kidney Int. 2008 Feb;73(4):391-8. doi: 10.1038/sj.ki.5002585. Epub 2007 Dec 19.

    PMID: 18094682BACKGROUND

  • Kaysen GA, Gambertoglio J, Jimenez I, Jones H, Hutchison FN. Effect of dietary protein intake on albumin homeostasis in nephrotic patients. Kidney Int. 1986 Feb;29(2):572-7. doi: 10.1038/ki.1986.36.

    PMID: 3702214BACKGROUND

  • Barsotti G, Morelli E, Cupisti A, Bertoncini P, Giovannetti S. A special, supplemented 'vegan' diet for nephrotic patients. Am J Nephrol. 1991;11(5):380-5. doi: 10.1159/000168342.

    PMID: 1809035BACKGROUND

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

ketosteril

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Anna Matyjek

    Military Institute of Medicine National Research Institute

    STUDY CHAIR

Central Study Contacts

Anna Matyjek, MD, PhD

CONTACT

261817045amatyjek@wim.mil.pl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomization in 1:1 ratio with stratification by the type of glomerular disease (podocytopathy versus other type) and investigational site
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

January 3, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)