Characterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to SocNCT06210464
Disease and Biomarker Profiling of Chinese Lupus Nephritis
An observational study of Characterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to Soc and Integrated Analysis of LN Patient Molecular Profiling and Clinical Annotations to Understand LNdisease Heterogeneity for Disease Endotype, run by Nan Shen.
Trial summary
In the proposed study , Novartis Institutes of Biomedical Research ( NIBR ) collaborates with Reni HospitalAffiated to Shanghai Jiaotong University School of Medicine ( Ren ) , aiming to identify particular LNendotype , and to discover novel biomarkers which link the endotype to disease phenotype , especially… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Characterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to Soc, Integrated Analysis of LN Patient Molecular Profiling and Clinical Annotations to Understand LNdisease Heterogeneity for Disease Endotype, Validate the Association of the Candidate Biomarker Panel Proposed in Table 3-1 With LN Diseasemonitoring
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2024to 1 Mar 2025
- 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 75 years
- All sexes
- Adult, Older adult
Study population: aged 18 years and 75 years
Who may be able to join
- 1. Able to communicate well with investigator, understand the study procedures and provide writteninformed consent before any study-related sample/data are accesse 2. Men and women with systemic lupus erythematosus (see below), aged 18 years and 75 years fulfilling 1997 ACR classification criteria for SLE, or 2012 SLICC classification criteria for SLE,OI2020 eularacr classification criteria for sstological diagnosis of proliferative lupusnephritis wealth OrganizationO)ISN/RPS (Weening et al 2004) Class I or class IV,with soc treatment anddisease monitoringleast one year 3. Serum/plasma and urine samples were collected at baseline of the treatme
Who cannot join
- 1.Presence of another autoimmune rheumatic disease that is active and constitutes the principalIllness , except for rheumatoid arthritis , Sjogrens syndrome and autoimmune thyroiditis 2 . Any glomerulonephritis other than WHO Class l or V lupus nephritis Patients with proliferativenephritis ( Class l or V ) who , in addition , have overlapping histological signs for other glomerulonephritis , e.g. , Class V are eligible at the investigator s discretion 3. History of malignancy with the exception of basal cell or squamous cell carcinoma of the skin orsitu carcinoma of the cervix within the last 2 vears 4 . Urinary system infection 5 . Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
In the proposed study , Novartis Institutes of Biomedical Research ( NIBR ) collaborates with Reni HospitalAffiated to Shanghai Jiaotong University School of Medicine ( Ren ) , aiming to identify particular LNendotype , and to discover novel biomarkers which link the endotype to disease phenotype , especially todisease monitorng , treatment response and prognosis prediction . The study proposes to take bothcandidate approach ( reported biomarkers ) and unbiased high-throughput proteomics profiling tools( Somascan measures up to 7,000 protein analytes ) to analyze 100 Class I / V LN patients with welldocumented clinical annotation , treatment schedule and disease follow up . Both serum / plasma and urrpatients will be extensively characterized with a focus on non-invasive biomarkediscovery and validation . Integrated analysis will be performed to associate patient molecular signature withtheir clinical annotation , renal pathology features , and response to Soc treatment . We will generahypothesis from these analyses to propose molecular markers to predict patient response to Soc treatmentand to endotype the disease , discover the mechanisms that could contrbute to unsatisfactory response toSoc , and identity more specific and sensitive non-invasive biomarkers in serum or urine that can be used in disease monitoring , disease prognosis and patient stratificationproposed study Will help usunderstand the heterogeneity of LN at the molecular level , which could be an essential first step towardsLN precision medicine . It will provide scientific rationale for improved LN clinical diagnosis , novel therapeutichypothesis , patient stratification , clinical study design and combination strategy.
- Conditions
- Characterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to Soc, Integrated Analysis of LN Patient Molecular Profiling and Clinical Annotations to Understand LNdisease Heterogeneity for Disease Endotype, Validate the Association of the Candidate Biomarker Panel Proposed in Table 3-1 With LN Diseasemonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Trial have no Intervention measures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum SDMA : serum EMIT or LC-MS assayUrinary
Measured: 2025
SCD163 : urine ELISA assay
Measured: 2025
Urine RALL Index ( NGAL , KIM-1 , MCP-1 , Adiponectin , Ceruloplasmin andHemopexin ) 4-plex panel ELLA and two single-plex ELISA
Measured: 2025
Urine Creatinine urine BM data normalization , enzymatic method on Cobas
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start14 Feb 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Characterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to SocStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nan Shen
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Nan Shen, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210464
- Sponsor's protocol ID
- BASICHR0060
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease and Biomarker Profiling of Chinese Lupus Nephritis
- ClinicalTrials.gov ID
- NCT06210464
- Acronym / sponsor ID
- BASICHR0060
- Conditions
- Characterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to Soc, Integrated Analysis of LN Patient Molecular Profiling and Clinical Annotations to Understand LNdisease Heterogeneity for Disease Endotype, Validate the Association of the Candidate Biomarker Panel Proposed in Table 3-1 With LN Diseasemonitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nan ShenUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 14 Feb 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 18 Jan 2024 (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.
In the proposed study , Novartis Institutes of Biomedical Research ( NIBR ) collaborates with Reni HospitalAffiated to Shanghai Jiaotong University School of Medicine ( Ren ) , aiming to identify particular LNendotype , and to discover novel biomarkers which link the endotype to disease phenotype , especially todisease monitorng , treatment response and prognosis prediction . The study proposes to take bothcandidate approach ( reported biomarkers ) and unbiased high-throughput proteomics profiling tools( Somascan measures up to 7,000 protein analytes ) to analyze 100 Class I / V LN patients with welldocumented clinical annotation , treatment schedule and disease follow up . Both serum / plasma and urrpatients will be extensively characterized with a focus on non-invasive biomarkediscovery and validation . Integrated analysis will be performed to associate patient molecular signature withtheir clinical annotation , renal pathology features , and response to Soc treatment . We will generahypothesis from these analyses to propose molecular markers to predict patient response to Soc treatmentand to endotype the disease , discover the mechanisms that could contrbute to unsatisfactory response toSoc , and identity more specific and sensitive non-invasive biomarkers in serum or urine that can be used in disease monitoring , disease prognosis and patient stratificationproposed study Will help usunderstand the heterogeneity of LN at the molecular level , which could be an essential first step towardsLN precision medicine . It will provide scientific rationale for improved LN clinical diagnosis , novel therapeutichypothesis , patient stratification , clinical study design and combination strategy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- aged 18 years and 75 years
Key inclusion criteria (1 listed)
- 1. Able to communicate well with investigator, understand the study procedures and provide writteninformed consent before any study-related sample/data are accesse 2. Men and women with systemic lupus erythematosus (see below), aged 18 years and 75 years fulfilling 1997 ACR classification criteria for SLE, or 2012 SLICC classification criteria for SLE,OI2020 eularacr classification criteria for sstological diagnosis of proliferative lupusnephritis wealth OrganizationO)ISN/RPS (Weening et al 2004) Class I or class IV,with soc treatment anddisease monitoringleast one year 3. Serum/plasma and urine samples were collected at baseline of the treatme
Key exclusion criteria (1 listed)
- 1.Presence of another autoimmune rheumatic disease that is active and constitutes the principalIllness , except for rheumatoid arthritis , Sjogrens syndrome and autoimmune thyroiditis 2 . Any glomerulonephritis other than WHO Class l or V lupus nephritis Patients with proliferativenephritis ( Class l or V ) who , in addition , have overlapping histological signs for other glomerulonephritis , e.g. , Class V are eligible at the investigator s discretion 3. History of malignancy with the exception of basal cell or squamous cell carcinoma of the skin orsitu carcinoma of the cervix within the last 2 vears 4 . Urinary system infection 5 . Pregnant women
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 |
|---|---|---|
| Trial have no Intervention measures. | Other | – |
Primary outcome
Serum SDMA : serum EMIT or LC-MS assayUrinary
Time frame: 2025
SCD163 : urine ELISA assay
Time frame: 2025
Urine RALL Index ( NGAL , KIM-1 , MCP-1 , Adiponectin , Ceruloplasmin andHemopexin ) 4-plex panel ELLA and two single-plex ELISA
Time frame: 2025
Urine Creatinine urine BM data normalization , enzymatic method on Cobas
Time frame: 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Characterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to Soc and Integrated Analysis of LN Patient Molecular Profiling and Clinical Annotations to Understand LNdisease Heterogeneity for Disease Endotype, run by Nan Shen.
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 1 inclusion and 1 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Nan Shen, doctor (13681723965, nanshensibs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum SDMA : serum EMIT or LC-MS assayUrinary (time frame: 2025). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2024.