Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis Clinical Trial
Official title:
Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphataemia Receiving Hemodialysis
| Verified date | January 2017 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
| Status | Completed |
| Enrollment | 1078 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Chronic renal failure patients with hyperphosphataemia receiving hemodialysis |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety assessed by the incidence of adverse events, physical exam and lab-tests | for one year | ||
| Secondary | Serum phosphate level | Baseline and 1, 2, 3, 6, 12 months after administration | ||
| Secondary | Serum calcium level | Baseline and 1, 2, 3, 6, 12 months after administration | ||
| Secondary | Intact PTH (parathyroid hormone) level | Baseline and 1, 2, 3, 6, 12 months after administration |