Lupus NephritisNCT06167174
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis
An observational study of Lupus Nephritis, run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus Nephritis
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 5 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All patients visit Rheumatology and Immunology Department of Peking Union Medical College Hospital and fulfill the inclusion criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Xinping Tian, MD, 86-13691165939, tianxp6@126.com
About this study
Official title: Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics
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.
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response of patients
The proportion of patients who achieve complete response, partial response or no response 24 weeks after baseline
Measured: 24 weeks
Secondary outcomes (2)
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.
Measured: 24 weeks
Adverse events during the study
All adverse events, severe adverse events and proportion of patients who discontinued the treatment due to adverse events within the duration of the study.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start5 Dec 2023 (estimated)
- Primary completion5 Dec 2027 (estimated)
- Study completion5 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinping Tian, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167174
- Sponsor's protocol ID
- CSTAR-K2939
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics
- ClinicalTrials.gov ID
- NCT06167174
- Acronym / sponsor ID
- CSTAR-K2939
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 5 Dec 2023 (estimated)
- Primary completion
- 5 Dec 2027 (estimated)
- Study completion
- 5 Dec 2028 (estimated)
- First posted
- 12 Dec 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All patients visit Rheumatology and Immunology Department of Peking Union Medical College Hospital and fulfill the inclusion criteria.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment response of patients
Time frame: 24 weeks
The proportion of patients who achieve complete response, partial response or no response 24 weeks after baseline
2 secondary outcomes
Disease progression
Time frame: 24 weeks
Adverse events during the study
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Xinping Tian, MD principal investigator
Peking Union Medical College Hospital
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 Lupus Nephritis, run by Chinese SLE Treatment And Research Group at 1 site in China.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Dec 2023. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinping Tian, MD (86-13691165939, tianxp6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response of patients (time frame: 24 weeks). 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 12 Dec 2023.