Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01901107

Enrollment

1078

Registered

2013-07-17

Start date

2013-01-31

Completion date

2016-12-31

Last updated

2017-01-27

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

Conditions

Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis

Keywords

Hemodialysis, CKD (chronic kidney disease), ASP1585, Hyperphosphatemia

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.

Interventions

DRUGKiklin capsules

oral

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Chronic renal failure patients with hyperphosphataemia receiving hemodialysis

Design outcomes

Primary

Measure	Time frame
Safety assessed by the incidence of adverse events, physical exam and lab-tests	for one year

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

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