Helicobacter pylori eradication therapy with vonoprazan, clarithromycin, and metronidazole for chronic kidney disease patients

JRCT ID: jRCTs031200239

Registered date:11/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 01/02/2021
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Vonoprazan (20mg), clarithromycin (200mg), and metronidazole (250mg) given on twice daily for 7days

Outcome(s)

• Primary Outcome: Eradication rate (FAS)

Secondary Outcome

(1) Eradication rate (PPS)
(2) Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients infected with Helicobacter pylori. Positive patients by Urea breath test, stool Helicobacter pylori antigen test, anti-Helicobacter pylori antibody test (blood), Helicobacter pylori culture, rapid urease test, or histrogical diagnosis of Helicobacter pylori are treated with infected.
Patients who underwent upper gastrointestinal endoscopy and diagnosed as gastritis, gastric ulcer, duodenal ulcer, gastric MALT lymphoma, after endoscopic treatment for early gastric cancer, or idiopathic thrombocytopenic purpura.
Patients whose eGFR revel is from 10mL/min/1.73m2 to 45mL/min/1.73m2 at the study entry, and diagnosed as chronic kidney disease.
Patients who give a written informed consent.

• Exclude criteria: Patients who have Helicobacter pylori eradication history. Hemodialysis patients for renal failure. Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. Patients using atazanavir, rilpivirine, pimozide, ergotamine, suvorexant, lomitapide mesylate, tadalafil, ticagrelor, ibrutinib, asuna previr, ivavradine, venetoclax, colchicine, lurasidone hydrochloride, anamorelin hydrochloride, finerenone, or isavuconazonium sulfate. A patient with brain and spinal cord disease. Patients who are disqualified for the study by physicians.

Related Information

• Primary Sponsor: Sue Soichiro
• Source(s) of Monetary Support: Yokohama City University