A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy

January 13, 2026 updated by: Guisen Li, Sichuan Provincial People's Hospital

A Multicenter Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy

To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male or female, aged 18 to 75 years, diagnosed with primary IgA nephropathy through renal biopsy within 3 months, with eGFR ≥ 30ml/min/1.73m2, 24-hour urinary protein ≥ 1.0g/d, and blood pressure<140/90mmHg

Description

Inclusion Criteria:

  1. Target patients aged 18-75, including those aged 18 and 75
  2. Primary IgA nephropathy diagnosed by renal biopsy within 3 months
  3. eGFR≥30ml/min/1.73m2
  4. 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g
  5. Sign informed consent

Exclusion Criteria:

  1. Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis
  2. Patients who have received kidney transplantation or dialysis
  3. Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria>3.5 g/d, serum albumin<3.0 g/dl, with or without edema)
  4. Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections
  5. Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c>8%)
  6. Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias
  7. Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg)
  8. Patients diagnosed with malignant tumors within the past 5 years
  9. Patients with known glaucoma, known cataracts, and/or a history of cataract surgery
  10. Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea
  11. Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms
  12. Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment
  13. Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment
  14. Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4)
  15. Current or previous (within the past 2 years) alcoholism or drug abuse;
  16. Expected lifespan<5 years
  17. During the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential)
  18. Researchers believe that patients who are not suitable for treatment with Nefecon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The changes in proteinuria levels
Time Frame: about 12 months
To evaluate the changes in proteinuria levels of the target patient in the 12th month compared to baseline
about 12 months
Number of Participants With clinical significant Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Time Frame: about 12 months
Safety event
about 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Evaluate the changes in eGFR of target patients at the 12th month compared to baseline
Time Frame: about 12 months
about 12 months
Evaluate the changes in microscopic hematuria of the target patient at the 12th month compared to baseline
Time Frame: about 12 months
about 12 months
Assess the incidence of composite renal endpoint events (eGFR decreased by 40% from baseline or ESKD) in target patients
Time Frame: about 12 months
about 12 months
Assess the incidence of ESKD (eGFR<15ml/min/1.73m2) in target patients at the 12th month
Time Frame: about 12 months
about 12 months
Evaluate the proportion of target patients with a 40% decrease in eGFR compared to baseline at the 12th month
Time Frame: about 12 months
about 12 months
Evaluate the proportion of target patients whose average urinary protein level decreased by 50% from baseline in the 12th month
Time Frame: about 12 months
about 12 months
Evaluate the changes in serum and urine proteomics and metabolomics of the target patient in the 12th month
Time Frame: about 12 months
about 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Evaluate the changes in GD-IgA1 levels of the target patient at 12 months compared to baseline.
Time Frame: about 12 months
about 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEF-EM-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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