Overview

This trial is active, not recruiting.

Condition chronic renal failure patients with hyperphosphataemia receiving hemodialysis
Treatment kiklin capsules
Sponsor Astellas Pharma Inc
Start date January 2013
End date December 2016
Trial size 1078 participants
Trial identifier NCT01901107, KIK001

Summary

The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
kiklin capsules ASP1585
oral

Primary Outcomes

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

Secondary Outcomes

Measure
Serum phosphate level
time frame: Baseline and 1, 2, 3, 6, 12 months after administration
Serum calcium level
time frame: Baseline and 1, 2, 3, 6, 12 months after administration
Intact PTH (parathyroid hormone) level
time frame: Baseline and 1, 2, 3, 6, 12 months after administration

Eligibility Criteria

Male or female participants of any age.

Chronic renal failure patients with hyperphosphataemia receiving hemodialysis

Additional Information

Official title Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphataemia Receiving Hemodialysis
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.