Chronic renal failure
Conditions
Interventions
Patients on sevelamer are to switch to bixalomer (dosed at 1500-7500 mg a day), and their serum phosphorus level is to be controlled by bixalomer. *For those who meet the Case 1 in the inclusion crit
Sponsors
Keijukai Healthcare Corporation,Saitama Tsukinomori Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with chronic renal failure under hemodialysis who fall into i) or ii): i) Patients currently on sevelamer hydrochloride who want to switch to bixalomer for some reasons; for instance, they are reluctant to take sevelamer due to its gastrointestinal side-affects; or, they cannot increase its dose sufficiently because of those reactions (Case 1) ii) Patients who discontinued sevelamer in the past because of its side-effects such as gastrointestinal dysfunction, and want to change their medication to bixalomer while currently taking another agent for hyperphosphatemia (Case 2) 2) Aged 20 or older 3) Patients able to consent to their participation in writing by themselves
Exclusion criteria
Exclusion criteria: 1) Patients with an intestinal blockage 2) Patients suffering from severe astriction or diarrhea continuously 3) Patients who have experienced gastrointestinal tract ulcer or a surgery in the abdomen 4) Patients with liver dysfunction (whose AST or ALT value is more than twice, or T-Bil value is more than 1.5 times higher than the standard level of the hospital they visit), or patients with a severe hepatic disorder such as cirrhosis 5) Patients who are expecting a child, lactating or suspected of pregnancy, or patients who want to be pregnant during their participation in this study 6) Patients considered as ineligible for this study by the investigator for another reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the serum phosphorus level over the 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Changes in digestive symptoms over the 12 weeks (assessed with the Izumo scale questionnaire) 2)Changes in medications for astriction 3)The dose of bixalomer which reaches the same level of serum phosphorus as that of sevelamer hydrochloride did before switch to bixalomer 4)Changes in a dose of bixalomer over the 12 weeks 5)Changes in a dose of calcium carbonate over the 12 weeks 6)Changes in the serum phosphorus level over the 4 weeks prior to bixalomer initiation and the last 4 weeks of the observational period (8-12 weeks after initiation) | — |
Countries
Japan
Outcome results
None listed