Primary IgA NephropathyNCT06589752
Replication of the NefIgArd Trial of TRF-budesonide in Primary IgAN
An observational study of Primary IgA Nephropathy, run by Ruijin Hospital at 1 site in China.
Trial summary
This replication of the NefIgArd trial of TRF-budesonide aims to use real-world data to evaluate the efficiency and safety of TRF-budesonide in the treatment of IgA nephropathy, from completing real-world research to providing real-world evidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary IgA Nephropathy
- What is being tested?
- TARPEYO 4 MG Delayed Release Oral Capsule and RAS inhibitor
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2023to 5 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary IgA nephropathy
Who may be able to join
- Male or female patients aged ≥18 years;
- Primary IgA nephropathy confirmed by renal biopsy;
- Stable use of RAS blockers;
- 24-hour urine albumin quantitation ≥1g/day, or urine protein/creatinine ratio ≥0.8g/g (≥90 mg/mmol);
- eGFR ≥30 mL/min/1.73m².
Who cannot join
- Systemic diseases that may cause interstitial IgA deposition, including but not limited to anaphylactoid purpura, systemic lupus erythematosus, herpetic dermatitis, and ankylosing spondylitis;
- Patients who have received kidney transplants;
- Those with other glomerular diseases (such as C3 glomerular disease or diabetic nephropathy) and nephrotic syndrome;
- Patients with acute, chronic, or latent infectious diseases, including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections;
- Patients with cirrhosis or severe liver function impairment, as assessed by the investigator;
- Patients diagnosed with poorly controlled type 1 or type 2 diabetes;
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- Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or arrhythmia as assessed by the investigator;
- Patients with poorly controlled blood pressure with systolic or diastolic blood pressure ≥140mmHg or 90mmHg. At least one blood pressure measurement should be in the above range (based on up to three measurements, 1 minute apart, taken after resting in the supine position for at least 5 minutes);
- Patients diagnosed with malignancy within the last 5 years, with the exception of treated basal cell carcinoma of the skin, curably resected squamous cell carcinoma of the skin, polyps of the colon, or carcinoma in situ of the cervix;
- Patients with osteoporosis who are known to be at moderate or high risk. Chinese patients are defined according to the Asian Osteoporosis Self-Assessment Tool (OSTA) Index;
- Patients with known glaucoma, known history of cataract and/or cataract surgery that may interfere with study drug action or release (such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea);
- Patients who are allergic to budesonide or any component of the investigational drug formulation;
- Patients who have previously had a severe adverse reaction to steroids;
- Patients with psychotic symptoms;
- Have received any systemic glucocorticoid therapy within 3 months prior to medication;
- Received immunosuppressants or biologics within 3 months prior to medication;
- Patients taking potent inhibitors of the cytochrome P450 3A4 enzyme (CYP3A4);
- Current or former (within the last 2 years) alcohol or drug abuse;
- Patients who are unwilling or unable to meet program requirements;
- Life expectancy <5 years;
- Women who are pregnant, nursing, or unwilling to use contraception during treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Replication of the NefIgArd Trial of Effectiveness and Safety of a Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
This replication of the NefIgArd trial of TRF-budesonide aims to use real-world data to evaluate the efficiency and safety of TRF-budesonide in the treatment of IgA nephropathy, from completing real-world research to providing real-world evidence.
Read the detailed description
Currently, TRF-budesonide are the first specific treatment for IgA nephropathy that targets intestinal mucosal immunity. Results from part A of the Phase III clinical trial (NCT03643965) show that compared to the placebo group, the TRF-budesonide group significantly reduced proteinuria and hematuria, stabilized renal function, and lowered circulating Gd-IgA1 levels at 12 months. However, further real-world studies are needed to verify the efficiency and safety of this treatment for IgA nephropathy. Therefore, this replication trial of the part A of the Phase III clinical trial NefIgArd and evaluates the efficiency and safety of TRF-budesonide in treating IgA nephropathy based on existing observational data, aiming to complete real-world research to provide real-world evidence that can guide clinical practice for IgA nephropathy treatment.
- Conditions
- Primary IgA Nephropathy
- Being tested
- TARPEYO 4 MG Delayed Release Oral Capsule, RAS inhibitor
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARPEYO 4 MG Delayed Release Oral CapsuleDrug
TARPEYO dispensing claim for any dose is exposure
RAS inhibitorDrug
RASi dispensing claim for any dose is reference
| Study group | Role | What they receive |
|---|---|---|
| Treat | TRF-budesonide enteric-coated capsule（TARPEYO） Receives: Drug: TARPEYO 4 MG Delayed Release Oral Capsule | |
| Control | RAS blocker Receives: Drug: RAS inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Protein Levels from Baseline at 9 months Primary endpoint
Assessment of the change in 24-hour urine protein levels from baseline after 9 months of follow-up.
Measured: 9 months
Change in eGFR from Baseline at 9 Months
Measurement of the change in estimated glomerular filtration rate (eGFR) from baseline after 9 months of follow-up.
Measured: 9 months
Secondary outcomes (3)
Change in 24-Hour Urine Protein Levels Compared to Baseline at 12 Months
Assessment of the change in 24-hour urine protein levels from baseline after 12 months of follow-up.
Measured: 12 months
Change in eGFR Compared to Baseline at 12 Months
Measurement of the change in estimated glomerular filtration rate (eGFR) from baseline after 12 months of follow-up.
Measured: 12 months
Incidence Rate of Adverse Events
Calculation of the incidence rate of adverse events during the study period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Apr 2023
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Jingyuan, MD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589752
- Sponsor's protocol ID
- RepIgAN
- Status last verified
- Sep 2024
- First submitted
- 21 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication of the NefIgArd Trial of Effectiveness and Safety of a Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT06589752
- Acronym / sponsor ID
- RepIgAN
- Conditions
- Primary IgA Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (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 replication of the NefIgArd trial of TRF-budesonide aims to use real-world data to evaluate the efficiency and safety of TRF-budesonide in the treatment of IgA nephropathy, from completing real-world research to providing real-world evidence.
Detailed description
Currently, TRF-budesonide are the first specific treatment for IgA nephropathy that targets intestinal mucosal immunity. Results from part A of the Phase III clinical trial (NCT03643965) show that compared to the placebo group, the TRF-budesonide group significantly reduced proteinuria and hematuria, stabilized renal function, and lowered circulating Gd-IgA1 levels at 12 months. However, further real-world studies are needed to verify the efficiency and safety of this treatment for IgA nephropathy. Therefore, this replication trial of the part A of the Phase III clinical trial NefIgArd and evaluates the efficiency and safety of TRF-budesonide in treating IgA nephropathy based on existing observational data, aiming to complete real-world research to provide real-world evidence that can guide clinical practice for IgA nephropathy treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treat | – | Drug: TARPEYO 4 MG Delayed Release Oral CapsuleTRF-budesonide enteric-coated capsule（TARPEYO） |
| Control | – | Drug: RAS inhibitorRAS blocker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary IgA nephropathy
Key inclusion criteria (5 listed)
- Male or female patients aged ≥18 years;
- Primary IgA nephropathy confirmed by renal biopsy;
- Stable use of RAS blockers;
- 24-hour urine albumin quantitation ≥1g/day, or urine protein/creatinine ratio ≥0.8g/g (≥90 mg/mmol);
- eGFR ≥30 mL/min/1.73m².
Key exclusion criteria (21 listed)
- Systemic diseases that may cause interstitial IgA deposition, including but not limited to anaphylactoid purpura, systemic lupus erythematosus, herpetic dermatitis, and ankylosing spondylitis;
- Patients who have received kidney transplants;
- Those with other glomerular diseases (such as C3 glomerular disease or diabetic nephropathy) and nephrotic syndrome;
- Patients with acute, chronic, or latent infectious diseases, including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections;
- Patients with cirrhosis or severe liver function impairment, as assessed by the investigator;
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 |
|---|---|---|
| TARPEYO 4 MG Delayed Release Oral CapsuleTARPEYO dispensing claim for any dose is exposure | Drug | Treat |
| RAS inhibitorRASi dispensing claim for any dose is reference | Drug | Control |
Primary outcome
Change in Urinary Protein Levels from Baseline at 9 months Primary endpoint
Time frame: 9 months
Assessment of the change in 24-hour urine protein levels from baseline after 9 months of follow-up.
Change in eGFR from Baseline at 9 Months
Time frame: 9 months
Measurement of the change in estimated glomerular filtration rate (eGFR) from baseline after 9 months of follow-up.
3 secondary outcomes
Change in 24-Hour Urine Protein Levels Compared to Baseline at 12 Months
Time frame: 12 months
Change in eGFR Compared to Baseline at 12 Months
Time frame: 12 months
Incidence Rate of Adverse Events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Primary IgA Nephropathy, run by Ruijin Hospital 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 5 inclusion and 21 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary Protein Levels from Baseline at 9 months Primary endpoint (time frame: 9 months). The study lists 2 primary outcomes in all. 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 19 Sep 2024.