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

The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: JWC containing quadruple therapy; Drug: Bismuth-containing quadruple therapy

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JWC group; Jinghua Weikang Capsule containing quadruple therapy.	Drug: JWC containing quadruple therapy; Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.
Active Comparator: Control group; Bismuth-containing quadruple therapy.	Drug: Bismuth-containing quadruple therapy; Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradicaion rate	The Helicobacter pylori infection status was measured by 13-carbon breath test.	The forth week after the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood creatinine level	The change of average blood creatinine level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Blood urea nitrogen level	The change of average blood urea nitrogen level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
eGFR	The change of average eGFR level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
24hrs urine protein level	The change of average24hrs urine protein level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Blood presure	The change of average blood presure level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
IgA level	The change of average IgA level level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
IgA1 level	The change of average IgA1 level between two groups.	Baseline, the third and sixth month after the treatment, respectively.
Gd-IgA1 level	The change of average Gd-IgA1 level level between two groups.	Baseline, the third and sixth month after the treatment, respectively.

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: HUI YE, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Eradication; IgA nephropathy; Bismuth-containing quadruple therapy; Jinghua Weikang Caplsule
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Bismuth
• Other Study ID Numbers: 2021CR36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared on https://clinicaltrials.gov.
• IPD Sharing Time Frame: The data will be uploaded within 6 month after Dec 31, 2024.
• IPD Sharing Access Criteria: The user of ClinicalTrials.gov PRS could access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No