Exploring Biomarkers for Therapeutic Response of Lupus Ne... | NCT06167174

Studies
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis

NCT06167174

Sponsor

Chinese SLE Treatment And Research Group

Status

Recruiting

Last Update Posted

Dec 12, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lupus Nephritis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2023Estimated

Primary Completion Date

Dec 5, 2027Estimated

Completion Date

Dec 5, 2028Estimated

First Submitted Date

Dec 4, 2023

First Submission Date that Met QC Criteria

Dec 4, 2023

First Posted Date

Dec 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2023

Last Update Posted Date

Dec 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational study of patients with lupus nephritis aiming to find biomarkers that can predict patients' response to immunosuppressants. We planed to collect 100 lupus nephritis patients' peripheral blood,kidney tissues and urine before and after treatment (mycophenolate mofetil or cyclophosphamide, in combination with glucocorticoids). Then multi omics analysis, including single cell RNA-seq, ATAC-seq and CITE-seq, will be performed to find new biomarkers for patients' response and prognosis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MMF treatment		Patients that have been diagnosed as III/IV ± V LN and treated with MMF 2g/d in combination with glucocorticoid.
CYC treatment		Patients that have been diagnosed as III/IV ± V LN and treated with CYC 0.5g IV per two weeks in combination with glucocorticoid.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment response of patients	The proportion of patients who achieve complete response, partial response or no response 24 weeks after baseline	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Disease progression	Clinical indices that can indicate the progression of disease, including 24-hour urinary protein, routine urine and blood tests, immune indices and patients' syndromes, will be evaluated at 4, 12, 24 weeks after baseline to monitor the progression of lupus nephritis.	24 weeks
Adverse events during the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 16-60 years.
Fulfilling the 2012 SLICC classification for SLE.
Renal biopsy pathology was clearly classified as III \ IV \ V+III \ V+IV within 6 months.
Renal biopsy reveals active disease.
24-hour urinary protein was tested twice within two weeks, both of which were greater than 1g.
The patients have never received glucocorticoid/immunosuppressants or received standard treatment for more than 1 month without change. The standard treatment should fulfill: a. prednisone 0-20mg/day, or equivalent other glucocorticoids; b. acceptable immunosuppressants, including Tacrolimus ≤ 4mg/d, methotrexate ≤ 15mg/week, azathioprine ≤ 100mg/d and MMF ≤ 1g/d.
Informed consent obtained.

Exclusion Criteria:

Other concomitant connective tissue diseases or autoimmune diseases.
Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, or other severe organ involvement.
Pregnant or lactating women.
Current infections that require antibiotic or antiviral treatment.
Other kidney diseases.
Platelet < 50×10^9/L.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is greater than 1.5 times the upper limit of the normal value.
Total bilirubin or blood lipid that is greater than 2 times the upper limit of the normal value.
Other conditions that not suitable for inclusion in the study, assessed by the investigators.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

All patients visit Rheumatology and Immunology Department of Peking Union Medical College Hospital and fulfill the inclusion criteria.

Sampling Method

Non-Probability Sample

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases