Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis

Completed

• Conditions: Chronic Renal Failure
• Interventions: Drug: bixalomer

• Registration Number: NCT01903213
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-19
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-19
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kiklin group	bixalomer	Oral

Primary Outcome Measures

Name	Time	Method
Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests	Baseline and 1, 2, 3, 6, 12 months after administration

Secondary Outcome Measures

Name	Time	Method
Serum phosphorous levels	Baseline and 1, 2, 3, 6, 12 months after administration
Serum calcium level	Baseline and 1, 2, 3, 6, 12 months after administration
Serum albumin level	Baseline and 1, 2, 3, 6, 12 months after administration
Serum intact PTH (parathyroid hormone) level	Baseline and 1, 2, 3, 6, 12 months after administration