Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection

NCT05320133 | Unknown

• 1 other identifier: 2021CR36
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; IgA nephropathy; Jinghua Weikang Caplsule; Bismuth-containing quadruple therapy; Eradication

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradicaion rate

  The Helicobacter pylori infection status was measured by 13-carbon breath test.

  The forth week after the treatment.

Secondary Outcomes (8)

• Blood creatinine level

  Baseline, the third and sixth month after the treatment, respectively.

• Blood urea nitrogen level

  Baseline, the third and sixth month after the treatment, respectively.

• eGFR

  Baseline, the third and sixth month after the treatment, respectively.

• 24hrs urine protein level

  Baseline, the third and sixth month after the treatment, respectively.

• Blood presure

  Baseline, the third and sixth month after the treatment, respectively.

Study Arms (2)

JWC group

EXPERIMENTAL

Jinghua Weikang Capsule containing quadruple therapy.

Drug: JWC containing quadruple therapy

Control group

ACTIVE COMPARATOR

Bismuth-containing quadruple therapy.

Drug: Bismuth-containing quadruple therapy

Interventions

JWC containing quadruple therapy DRUG

Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.

JWC group

Bismuth-containing quadruple therapy DRUG

Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IgA nephropathy diagnosed by renal biopsy;
• Current Helicobacter pylori infection;
• Age 18-65.

You may not qualify if:

• ①eGFR\<90ml/（min·1.73m2）-
• History of Helicobacter pylori treatment
• Present taking hormones or immunosuppressants
• Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of gastric mucosa
• Allergy history to medicines used in the study
• History of gastric surgery
• Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular diseases, respiratory diseases, mental disorders and other researchers are considered to affect treatment and assessment
• Combined with other primary or secondary nephropathy except for IgAN
• Combined with acute renal injury
• Female patients with pregnancy, lactation and planned pregnancy.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (1)

• 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.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• HUI YE

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 11, 2022
• Study Start: June 20, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will be uploaded within 6 month after Dec 31, 2024.
• Access Criteria: The user of ClinicalTrials.gov PRS could access the data.

Locations

CN (1)