Nephrotic SyndromeNCT04311684
Non-invasive Assessment of Mechano-chemical Properties of Urine Proteins by Hybrid Brillouin-Raman Spectroscopy
An observational study of Nephrotic Syndrome, run by Nazarbayev University at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- hybrid Brillouin-Raman spectroscopy
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteKazakhstan
- Study dates
- 6 Apr 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of Hybrid Brillouin-Raman Spectroscopy for Non-invasive Assessment of Mechano-chemical Properties of Urine Proteins as Biomarkers of Kidney Diseases
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.
- Conditions
- Nephrotic Syndrome
- Being tested
- hybrid Brillouin-Raman spectroscopy
- Keywords
- urinary proteins, Brillouin spectroscopy, surface enhanced Raman spectroscopy, proteomics, non-invasive assessment
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: hybrid Brillouin-Raman spectroscopy | |
| Healthy volunteers | Healthy men/women between age group 18-65 years will be included for urine protein measurements Receives: Device: hybrid Brillouin-Raman spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Correlation and cross-validation of urinary protein Brillouin and SERS spectroscopy measurements by Liquid Chromatography-Mass Spectrometry (with proteomic measurements).
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start6 Apr 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University
- Sponsor type
- University, hospital or other
- Collaborators
- National Scientific Medical Center, Kazakhstan, Astana Medical University
- Responsible party
- Sponsor
- Investigators
- Abduzhappar Gaipov, MD, PhD, Principal investigator, Nazarbayev University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311684
- Sponsor's protocol ID
- 091019CRP2105
- Status last verified
- Nov 2022
- First submitted
- 14 Mar 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35269733Aitekenov 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.
PubMed 35157535Aitekenov 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.
PubMed 33303164Gaipov 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.
PubMed 32539773Gaipov 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.
PubMed 36359427
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Hybrid Brillouin-Raman Spectroscopy for Non-invasive Assessment of Mechano-chemical Properties of Urine Proteins as Biomarkers of Kidney Diseases
- ClinicalTrials.gov ID
- NCT04311684
- Acronym / sponsor ID
- 091019CRP2105
- Conditions
- Nephrotic Syndrome
- Keywords
- urinary proteins, Brillouin spectroscopy, surface enhanced Raman spectroscopy, proteomics, non-invasive assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Nazarbayev UniversityUniversity, hospital or other
- Collaborators
- National Scientific Medical Center, Kazakhstan, Astana Medical University
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with proteinuria | – | Device: hybrid Brillouin-Raman spectroscopyPatients 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 |
| Healthy volunteers | – | Device: hybrid Brillouin-Raman spectroscopyHealthy men/women between age group 18-65 years will be included for urine protein measurements |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hybrid Brillouin-Raman spectroscopyCombination 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 | Device | Healthy volunteers, Patients with proteinuria |
Primary outcome
Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome
Time frame: four weeks
Urine sample measurements by Brillouin and surface enhanced Raman (SERS) spectroscopy
1 secondary outcome
Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Results publication: PubMed 35269733Ikramova 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.
- Results publication: PubMed 35157535Aitekenov 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.
- Results publication: PubMed 33303164Aitekenov 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.
- Results publication: PubMed 32539773Gaipov 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.
- Results publication: PubMed 36359427Gaipov 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abduzhappar Gaipov, MD, PhD principal investigator
Nazarbayev University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome, run by Nazarbayev University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive assessment of mechano-chemical properties of urine proteins by hybrid Brillouin-Raman spectroscopy in a patient with nephrotic syndrome (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311684, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.