Disease and Biomarker Profiling of Chinese Lupus Nephritis

January 13, 2024 updated by: Nan Shen
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

aged 18 years and 75 years

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Serum SDMA : serum EMIT or LC-MS assayUrinary
Time Frame: 2025
2025
SCD163 : urine ELISA assay
Time Frame: 2025
2025
Urine RALL Index ( NGAL , KIM-1 , MCP-1 , Adiponectin , Ceruloplasmin andHemopexin ) 4-plex panel ELLA and two single-plex ELISA
Time Frame: 2025
2025
Urine Creatinine urine BM data normalization , enzymatic method on Cobas
Time Frame: 2025
2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nan Shen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BASICHR0060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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