Chronic Kidney Disease, Hyperphosphatemia
Conditions
Keywords
ASP1585, Renal Dialysis, Chronic Kidney Disease, Hyperphosphatemia
Brief summary
To evaluate the superiority to placebo, dose-responsibility and safety.
Detailed description
This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent * Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent. * Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents
Exclusion criteria
* History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion * Continuous severe constipation/diarrhea. * History of parathyroid intervention \[parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.\] within 1 year of the acquisition of informed consent * Diet restriction such as fasting and/or excessive dieting * Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum phosphorus | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum phosphorus level by time | Up to 4 weeks |
| Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time | 4 Weeks |
| Change in corrected serum Ca level | 4 weeks |
| Change in Ca×P | 4 weeks |
| Change in intact PTH | 4 weeks |
Countries
Japan
Outcome results
None listed