IgA nephropathy steroid gargling therapy trail

Not Applicable

• Conditions: IgA nephropathy; D005922

• Registration Number: JPRN-jRCTs031200127
• Lead Sponsor: Suzuki Yusuke

Brief Summary

o significant oral adverse events were observed. Clinical markers related to inflammation and glucose intolerance were evaluated and showed no significant changes with the steroid gargling. The systemic effects of steroid gargling might be negligible. As for the possibility of a therapeutic effect, no significant changes were observed in serum IgA and Gd-IgA1 levels, proteinuria, and hematuria with the intervention. Thus, the therapeutic effect of steroid gargling therapy remains unclear.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-23
• Study Completion: 2022-07-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) Patients who received renal biopsy and diagnosed as IgA nephropathy in our hospital
2) Patients who are scheduled to arrange tonsillectomy first
3) Outpatients only.
4) Patients who are older than 20 years old at the time of informed consent

Exclusion Criteria

1) Patients who cannot provide written informed consent
2) Patients who are scheduled to arrange steroid pulse therapy first
3) Patients who are scheduled to follow up without treatemnt.
4) Patients with steroids or immunosuppressant usage prior to study entry
5) Pregnant women or lactating women
6) Patients with active intra-oral infection on examination
7) Patients who have episodes of oral candida or esophageal candida
8) Patients with rapid worsening of renal function
9) Patients with any active infection at study entry
10) Patients with malignancy at study entry
11) Patients with hepatitis C and other liver diseases
12) Any other patients that the researcher considers inappropriate for participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of steroid gargling (Adverse effects, Clinical data, Clinical findings, degree of inflammation, glucose intolerance)

Secondary Outcome Measures

Name	Time	Method
1) Clinical biomarkers of IgA nephropathy (serum IgA, serum Gd-IgA1, Creatinine, eGFR, urine protein/creatinine ratio, urine red blood cell count)<br>2) Adherence to steroid gargling therapy (treatment compliance, frequency of accidental ingestion)