Switching hemodialysis patients from sevelamer hydrochloride to bixalomer: a single-center, non-randomized controlled analysis of efficacy and effects on gastrointestinal symptoms and metabolic acidosis
- Conditions
- End-stage renal failure, Hemodialysis
- Registration Number
- JPRN-UMIN000011150
- Lead Sponsor
- OYOKYO Kidney Research Institute
- Brief Summary
Before switching, symptoms of epigastric fullness were significantly worse in the switch than in the control group. Twelve weeks after the switch, reflux, epigastric fullness, and constipation had improved significantly in the switch group. Other factors, including stomach ache, diarrhea, and form of stool, did not change significantly. Blood gas analysis showed that metabolic acidosis was significantly improved by switching. Four patients (14%) experienced grade 1 adverse events, all of which improved immediately after stopping BXL. Major adverse events were diarrhea and abdominal discomfort.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
Patients were excluded if they (1) had a history of gastrointestinal surgery (excluding polypectomy), dysphagia, ileus, gastrointestinal bleeding, severe persistent constipation or diarrhea, or had received parathyroid intervention within 3 months of study entry, (2) showed unstable control of serum phosphorus and calcium levels; or (3) were in poor general health, or had a major concomitant malignant disease or another medical condition likely to result in death within 6 months of study entry.
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of gastrointestinal symptoms 12 weeks after the switch
- Secondary Outcome Measures
Name Time Method Improvement in metabolic acidosis, changes in blood biochemistry, and safety 12 weeks after the switch