NCT04311684

Brief Summary

The proteinuria is widely recognized as a marker of kidney disease severity, as well as the predictor of renal function decline, cardiovascular outcomes, and all-cause mortality. However, the severity of kidney disease progression and these outcomes differs among patients with various amount of proteinuria. The potential mechanism underlining this disparity may be relevant to the quality and quantity of filtered proteins, especially their mechano-chemical properties such as physical viscosity and stiffness, amino-acid sequence, and molecular weight (low, middle and high molecular weight proteins). The goal of the current project is to develop and validate combined Brillouin \& Surface-Enhanced Raman Scattering (SERS) Spectroscopy technique for simultaneous non-contact assessment of visco-elastic and chemical properties of urine proteins as biomarkers of kidney disease. Systematic studies of these properties of proteins in urine samples to be taken from diseased and healthy subjects will be cross-validated by Liquid Chromatography-Mass Spectrometry (LCMS). The project ultimately aims for the development of an optical spectroscopic sensor for rapid, non-contact monitoring of urine samples from patients in clinical settings.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

April 6, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

2.7 years

First QC Date

March 14, 2020

Last Update Submit

November 11, 2022

Conditions

Nephrotic Syndrome

Keywords

urinary proteinsBrillouin spectroscopysurface enhanced Raman spectroscopyproteomicsnon-invasive assessment

Outcome Measures

Primary Outcomes (1)

  • Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome

    Urine sample measurements by Brillouin and surface enhanced Raman (SERS) spectroscopy

    four weeks

Secondary Outcomes (1)

  • Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome

    four weeks

Study Arms (2)

Patients with proteinuria

Patients with newly diagnosed glomerulonephritis with different range of proteinuria at the age between 18-65 years and estimated glomerular filtration rate (GFR) ≥60 ml/min will be included for urine protein measurements

Device: hybrid Brillouin-Raman spectroscopy

Healthy volunteers

Healthy men/women between age group 18-65 years will be included for urine protein measurements

Device: hybrid Brillouin-Raman spectroscopy

Interventions

hybrid Brillouin-Raman spectroscopyDEVICE

Combination of Brillouin and surface-enhanced Raman (SERS) spectroscopy for assessment of both visco-elastic (i.e. mechanical) and chemical characterization of urinary proteins at the same time from the same excitation laser source

Healthy volunteersPatients with proteinuria

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The proposed study will include 20 healthy subjects and age/gender matched 80 patients with newly diagnosed glomerulonephritis with different range of proteinuria at the age between 18-65 years and estimated glomerular filtration rate (GFR) ≥60 ml/min. Exclusion criteria will be patients aged \<18 and \>65 years, eGFR\<60 ml/min, pregnant females, patients with diabetes mellitus, cancer, infectious diseases and other life-treating comorbidities/conditions.

You may qualify if:

  • Both male and female patients with any ethnic group, aged between 18-65 years old
  • Newly diagnosed patients with glomerulonephritis and different range of proteinuria

You may not qualify if:

  • patients aged \<18 and \>65 years,
  • eGFR\<60 ml/min,
  • pregnant females,
  • patients with diabetes mellitus, cancer, infectious diseases, and other life-treating comorbidities/conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nazarbayev University School of Medicine

Astana, 010000, Kazakhstan

Location

Related Publications (5)

  • Ikramova SB, Utegulov ZN, Dikhanbayev KK, Gaipov AE, Nemkayeva RR, Yakunin VG, Savinov VP, Timoshenko VY. Surface-Enhanced Raman Scattering from Dye Molecules in Silicon Nanowire Structures Decorated by Gold Nanoparticles. Int J Mol Sci. 2022 Feb 26;23(5):2590. doi: 10.3390/ijms23052590.

    PMID: 35269733RESULT

  • Aitekenov S, Sultangaziyev A, Abdirova P, Yussupova L, Gaipov A, Utegulov Z, Bukasov R. Raman, Infrared and Brillouin Spectroscopies of Biofluids for Medical Diagnostics and for Detection of Biomarkers. Crit Rev Anal Chem. 2023;53(7):1561-1590. doi: 10.1080/10408347.2022.2036941. Epub 2022 Feb 14.

    PMID: 35157535RESULT

  • Aitekenov S, Gaipov A, Bukasov R. Review: Detection and quantification of proteins in human urine. Talanta. 2021 Feb 1;223(Pt 1):121718. doi: 10.1016/j.talanta.2020.121718. Epub 2020 Oct 14.

    PMID: 33303164RESULT

  • Gaipov A, Utegulov Z, Bukasov R, Turebekov D, Tarlykov P, Markhametova Z, Nurekeyev Z, Kunushpayeva Z, Sultangaziyev A. Development and validation of hybrid Brillouin-Raman spectroscopy for non-contact assessment of mechano-chemical properties of urine proteins as biomarkers of kidney diseases. BMC Nephrol. 2020 Jun 15;21(1):229. doi: 10.1186/s12882-020-01890-x.

    PMID: 32539773RESULT

  • Gaipov A, Makhammajanov Z, Dauyey Z, Markhametova Z, Mussina K, Nogaibayeva A, Kozina L, Auganova D, Tarlykov P, Bukasov R, Utegulov Z, Turebekov D, Soler MJ, Ortiz A, Kanbay M. Urinary Protein Profiling for Potential Biomarkers of Chronic Kidney Disease: A Pilot Study. Diagnostics (Basel). 2022 Oct 25;12(11):2583. doi: 10.3390/diagnostics12112583.

    PMID: 36359427RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Abduzhappar Gaipov, MD, PhD

    Nazarbayev University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2020

First Posted

March 17, 2020

Study Start

April 6, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

November 16, 2022

Record last verified: 2022-11

Locations

KA(1)