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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01903213

Enrollment

123

Registered

2013-07-19

Start date

2013-03-19

Completion date

2019-12-31

Last updated

2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure

Keywords

Peritoneal dialysis, Bixalomer, Chronic renal failure patients with Hyperphosphatemia, Kiklin®

Brief summary

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

Interventions

DRUGbixalomer

Oral

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Serum phosphorous levels	Baseline and 1, 2, 3, 6, 12 months after administration
Serum albumin level	Baseline and 1, 2, 3, 6, 12 months after administration
Serum calcium 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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026