IgA NephropathySURBINCT04805047
SodiUm Restriction by Behavioral Intervention
A study testing education and monitoring in people with IgA Nephropathy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The aim of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with immunoglobulin A nephropathy. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured education program in… Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- education and monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2021to Dec 2023
- Phase
- Interventional
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female or male patients>14 years of age and <70 years of age
- Diagnosed immunoglobulin A nephropathy with biopsy;
- eGFR>30ml/min per 1.73m2 using Chronic Kidney Disease Epidemiology Collaboration formula
- Proteinuria >1 g per day
- urinary sodium excretion >200 mmol per day within one month
- systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg, or a well-controlled blood pressure by treatment with antihypertensives including renin-angiotensin-aldosterone system-blockade (ACE-inhibitor or ARB)
- Written informed consent
Who cannot join
- Be treated with diuretics
- Blood pressure > 180 mmHg systolic or > 125 mmHg diastolic without medical treatment
- Have undergone renal transplantation
- With acute kidney injury (RIFLE criteria) < 6 months ago
- Cardiovascular or cerebrovascular event (myocardial infarction, cerebral hemorrhage or infarction) < 6 months ago
- With progressive malignancy or pregnancy
- With contraindications of RAAS blockers
- unwilling or unable to meet the requirements of the protocol
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Huixian Li, Master, 18691636705, lihuixian_muye@163.com
About this study
Official title: Sodium Restriction by Behavioral Intervention: Education and Monitoring
The aim of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with immunoglobulin A nephropathy. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured education program in combination with regular sodium excretion monitoring.
Read the detailed description
Patients in the intervention group receive regular sodium-restriction education by a dietician, which entails introducing food types and cooking skills, quantifying salt intake with a special spoon and recording detailed interactive food diary. Sodium excretion was measured using one 24-hour urine collection regularly to assess dietary compliance and enable feedback. The test persons with sodium excretion higher than 90mmol/24h will receive intensive education. Test persons in the control group receive standard care. After 2 weeks in study, all test persons visit the outpatient clinic for measurements and data collection. Within 3 months of total study duration, data collection and measurements take place at the end of every month.
At each timepoint blood and 24-hourly urine is collected, test persons fill out questionnaires.
- Conditions
- IgA Nephropathy
- Being tested
- education and monitoring
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and monitoringBehavioural
regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback
| Study group | Role | What they receive |
|---|---|---|
| Intervention:education and monitoring | Experimental | regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback Receives: Behavioral: education and monitoring |
| control | No intervention | regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour urine protein excretion
24 hour urine protein excretion after 3 months
Measured: 3 months
Secondary outcomes (4)
24 hour urine sodium excretion
24 hour urine sodium excretion after 3 months
Measured: 3 months
blood pressure
blood pressure after 3 months
Measured: 3 months
estimated Glomerular Filtration Rate change
estimated Glomerular Filtration Rate change after 3 months
Measured: 3 months
Psychological well-being
Psychological well-being will be assessed with multiple choice questionnaires
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start15 May 2021
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IgA NephropathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huixian Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805047
- Sponsor's protocol ID
- XJTU1AF2020LSK-073
- Acronym
- SURBI
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PubMed 38299639
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Restriction by Behavioral Intervention: Education and Monitoring
- ClinicalTrials.gov ID
- NCT04805047
- Acronym / sponsor ID
- SURBI / XJTU1AF2020LSK-073
- Conditions
- IgA Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Mar 2021 (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.
The aim of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with immunoglobulin A nephropathy. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured education program in combination with regular sodium excretion monitoring.
Detailed description
Patients in the intervention group receive regular sodium-restriction education by a dietician, which entails introducing food types and cooking skills, quantifying salt intake with a special spoon and recording detailed interactive food diary. Sodium excretion was measured using one 24-hour urine collection regularly to assess dietary compliance and enable feedback. The test persons with sodium excretion higher than 90mmol/24h will receive intensive education. Test persons in the control group receive standard care. After 2 weeks in study, all test persons visit the outpatient clinic for measurements and data collection. Within 3 months of total study duration, data collection and measurements take place at the end of every month.
At each timepoint blood and 24-hourly urine is collected, test persons fill out questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention:education and monitoring | Experimental | Behavioral: education and monitoringregular education programs supported by a dietician in combination with urine sodium monitoring as a feedback |
| control | No intervention | –regular care |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Female or male patients>14 years of age and <70 years of age
- Diagnosed immunoglobulin A nephropathy with biopsy;
- eGFR>30ml/min per 1.73m2 using Chronic Kidney Disease Epidemiology Collaboration formula
- Proteinuria >1 g per day
- urinary sodium excretion >200 mmol per day within one month
Key exclusion criteria (8 listed)
- Be treated with diuretics
- Blood pressure > 180 mmHg systolic or > 125 mmHg diastolic without medical treatment
- Have undergone renal transplantation
- With acute kidney injury (RIFLE criteria) < 6 months ago
- Cardiovascular or cerebrovascular event (myocardial infarction, cerebral hemorrhage or infarction) < 6 months ago
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 |
|---|---|---|
| education and monitoringregular education programs supported by a dietician in combination with urine sodium monitoring as a feedback | Behavioural | Intervention:education and monitoring |
Primary outcome
24 hour urine protein excretion
Time frame: 3 months
24 hour urine protein excretion after 3 months
4 secondary outcomes
24 hour urine sodium excretion
Time frame: 3 months
blood pressure
Time frame: 3 months
estimated Glomerular Filtration Rate change
Time frame: 3 months
Psychological well-being
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Derived from this study: PubMed 38299639Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
Related trials for IgA Nephropathy
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A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
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MYTP01 for Immune-Mediated Diseases
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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.
Huixian Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education and monitoring in people with IgA Nephropathy, run by First Affiliated Hospital Xi'an Jiaotong University 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 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 Apr 2022. 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?
Contact Huixian Li (17792905602 ext. 17792905602, lihuixian_muye@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour urine protein excretion (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805047, which also lists 1 linked publication.
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 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.