IgA NephropathyNCT04438603
The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
An observational study of IgA Nephropathy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Intervention for incipient patients at low risk of disease progression and Intervention for patients at high risk of disease progression
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Sep 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, RenJi Hospital, Shanghai Zhongshan Hospital, Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital
Who may be able to join
- 1. IgA nephropathy:
- Age: 18-80 years.
- Patients diagnosed with primary IgA nephropathy by renal biopsy.
- Estimated glomerular filtration rate (using the 2009 CKD-EPI formula) ≥30ml/min/1.73/m^2.
- Obtain informed consent from patients. 2. Healthy Control: Gender, age and ethnicity matched health volunteers. 3. IgAN patients were further divided into 4 groups, as defined below:
- 1) Long-term stable patients:
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- Follow-up for at least 15 years and meet at least one of the following:
- Annual eGFR loss rate <3ml/min/1.73m^2.
- eGFR>90ml/min/1.73m^2. 2) Non-progressive IgAN patients:
- Meet at least one of the following:
- eGFR decrease of more than 50% from baseline (in the absence of other possible causes of kidney damage).
- Annual eGFR loss rate >5ml/min/1.73m^2.
- Progress to ESRD. 3) IgAN patients at low risk of disease progression: Proteinuria ≤ 1g/24h after 3 months of optimized supportive care. 4) IgAN patients at high risk of disease progression: Proteinuria > 1g/24h despite 3 months of optimized supportive care.
Who cannot join
- Kidney biopsy shows crescentic IgAN or MCD-IgAN.;
- Patients with secondary IgAN;
- During pregnancy or lactation;
- After kidney transplantation;
- More than one serious acute infection in the psat 12 months;
- Chronic infection;
- Use of glucocorticosteroids and other immunosuppressive drugs within the last 6 months;
- Incomplete medical history or clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Jiang Gengru, +86-13917983703, jianggeng-ru@hotmail.com
About this study
This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.
Read the detailed description
Autoimmunity may play an important role in IgA nephropathy, and previous studies have shown that immune repertoire sequencing (IR-Seq) may help elucidate the dynamic changes of immune repertoire (IR) in autoimmune disease states. To further explore the potential application value of this technology, we will conduct a series of prospective studies to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.
- Conditions
- IgA Nephropathy
- Being tested
- Intervention for incipient patients at low risk of disease progression, Intervention for patients at high risk of disease progression
- Keywords
- IgA Nephropathy, IR-Seq, Biomarker
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for incipient patients at low risk of disease progressionDrug
Conservative treatment, if necessary use ACEI/ARB and titrated to the maximum tolerated dose, with a BP-lowering goal of < 130/80 mm Hg
Intervention for patients at high risk of disease progressionDrug
BP-lowering goal of < 125/75 mm Hg and treat with steroids or steroids combined with immunosuppressants based on optimal supportive therapy:
- If GFR>60 ml/min/1.73m^2, oral prednisone 0.6-0.8 mg/kg/day ( (maximum dose 48 mg/day) for 2 months, followed by a monthly dose reduction of 8 mg for 24 weeks.
- If GFR is 30-60 ml/min/1.73m^2, intravenous cyclophosphamide (CTX) 750 mg per month per m^2 for 6 months, along with oral prednisone (at the same dose as 1); if intravenous administration is unacceptable, then the above regimen was replaced with oral mycophenolate mofetil 500 mg bid for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IgAN patients at low risk of disease progression | n = 30, incipient disease Receives: Drug: Intervention for incipient patients at low risk of disease progression | |
| IgAN patients at high risk of disease progression | n = 60, incipient disease Receives: Drug: Intervention for patients at high risk of disease progression | |
| Long-term stable patients | n = 30, follow-up for at least 15 years | |
| Progressive IgAN patients | n = 30 | |
| Healthy control | n = 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary protein remission rate
Including complete and partial remission rate of urinary protein. Complete remission criteria: post-treatment urine protein <0.3 g/24h; partial remission criteria: post-treatment urine protein <50% of the maximum value.
Measured: 24 weeks
Secondary outcomes (3)
24-hour urine protein level
Measured: 24 weeks
Serum albumin level
Measured: 24 weeks
eGFR (estimated using the 2009 CKD-EPI formula)
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 posted19 Jun 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Shanghai Zhongshan Hospital, Longhua Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438603
- Sponsor's protocol ID
- XHEC-C-2020-070-1
- Status last verified
- Aug 2020
- First submitted
- 17 Jun 2020
- Last updated
- 28 Aug 2020
- 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 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
- ClinicalTrials.gov ID
- NCT04438603
- Acronym / sponsor ID
- XHEC-C-2020-070-1
- Conditions
- IgA Nephropathy
- Keywords
- IgA Nephropathy, IR-Seq, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- RenJi Hospital, Shanghai Zhongshan Hospital, Longhua Hospital
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 19 Jun 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.
This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.
Detailed description
Autoimmunity may play an important role in IgA nephropathy, and previous studies have shown that immune repertoire sequencing (IR-Seq) may help elucidate the dynamic changes of immune repertoire (IR) in autoimmune disease states. To further explore the potential application value of this technology, we will conduct a series of prospective studies to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IgAN patients at low risk of disease progression | – | Drug: Intervention for incipient patients at low risk of disease progressionn = 30, incipient disease |
| IgAN patients at high risk of disease progression | – | Drug: Intervention for patients at high risk of disease progressionn = 60, incipient disease |
| Long-term stable patients | – | –n = 30, follow-up for at least 15 years |
| Progressive IgAN patients | – | –n = 30 |
| Healthy control | – | –n = 30 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, RenJi Hospital, Shanghai Zhongshan Hospital, Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital
Key inclusion criteria (13 listed)
- Age: 18-80 years.
- Patients diagnosed with primary IgA nephropathy by renal biopsy.
- Estimated glomerular filtration rate (using the 2009 CKD-EPI formula) ≥30ml/min/1.73/m^2.
- Obtain informed consent from patients. 2. Healthy Control: Gender, age and ethnicity matched health volunteers. 3. IgAN patients were further divided into 4 groups, as defined below:
- Annual eGFR loss rate <3ml/min/1.73m^2.
Key exclusion criteria (8 listed)
- Kidney biopsy shows crescentic IgAN or MCD-IgAN.;
- Patients with secondary IgAN;
- During pregnancy or lactation;
- After kidney transplantation;
- More than one serious acute infection in the psat 12 months;
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 |
|---|---|---|
| Intervention for incipient patients at low risk of disease progressionConservative treatment, if necessary use ACEI/ARB and titrated to the maximum tolerated dose, with a BP-lowering goal of < 130/80 mm Hg | Drug | IgAN patients at low risk of disease progression |
| Intervention for patients at high risk of disease progressionBP-lowering goal of < 125/75 mm Hg and treat with steroids or steroids combined with immunosuppressants based on optimal supportive therapy: 1. If GFR>60 ml/min/1.73m^2, oral prednisone 0.6-0.8 mg/kg/day ( (maximum dose 48 mg/day) for 2 months, followed by a monthly dose reduction of 8 mg for 24 weeks. 2. If GFR is 30-60 ml/min/1.73m^2, intravenous cyclophosphamide (CTX) 750 mg per month per m^2 for 6 months, along with oral prednisone (at the same dose as 1); if intravenous administration is unacceptable, then the above regimen was replaced with oral mycophenolate mofetil 500 mg bid for 24 weeks. | Drug | IgAN patients at high risk of disease progression |
Primary outcome
Urinary protein remission rate
Time frame: 24 weeks
Including complete and partial remission rate of urinary protein. Complete remission criteria: post-treatment urine protein <0.3 g/24h; partial remission criteria: post-treatment urine protein <50% of the maximum value.
3 secondary outcomes
24-hour urine protein level
Time frame: 24 weeks
Serum albumin level
Time frame: 24 weeks
eGFR (estimated using the 2009 CKD-EPI formula)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
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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.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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 IgA Nephropathy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 13 inclusion and 8 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 28 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary protein remission rate (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 28 Aug 2020.