End-stage renal failure, Hemodialysis
Conditions
Interventions
Intervention group:Patients were switched from sevelamer hydrochloride to bixalomer (1:1 dose)
Control gtoup: Patients without sevelamer hydrochloride agent were enrolled as a control group
Sponsors
OYOKYO Kidney Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients were included if they (1) were aged 20 to 80 years, were stable on hemodialysis sessions started at least 1 year before study entry; (2) provided written informed consent to participation; (3) had not changed their 9 regimen of phosphate-lowering drugs, cinacalcet hydrochloride (if used), and other medications that could affect serum phosphorus levels for at least 28 days before study entry; (4) had not changed their dialysis regimens for at least 28 days before study entry; (5) had not changed other factors, including dietary therapy and concomitant drugs, during the study period; and (6) were in good general health, with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) grade of 0 or 1
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of gastrointestinal symptoms 12 weeks after the switch | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in metabolic acidosis, changes in blood biochemistry, and safety 12 weeks after the switch | — |
Countries
Japan
Contacts
Public ContactShingo Hatakeyama
Hirosaki University, School of Medicine Urology
Outcome results
None listed