Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
Completed
- Conditions
- Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis
- Interventions
- Drug: Kiklin capsules
- Registration Number
- NCT01901107
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
- Detailed Description
Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1078
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Kiklin group Kiklin capsules -
- Primary Outcome Measures
Name Time Method Safety assessed by the incidence of adverse events, physical exam and lab-tests for one year
- Secondary Outcome Measures
Name Time Method Serum phosphate level Baseline and 1, 2, 3, 6, 12 months after administration Serum calcium level Baseline and 1, 2, 3, 6, 12 months after administration Intact PTH (parathyroid hormone) level Baseline and 1, 2, 3, 6, 12 months after administration