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OpenTrials
Completed

NCT Number: NCT01901107

Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients

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

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Key information

Conditions

Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphosphatemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chūbu, Chubu, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Chronic renal failure patients with hyperphosphataemia receiving hemodialysis

Treatment and study plan

Kiklin capsules

Drug

oral

Other names: ASP1585, ILY101, AMG223, bixalomer

Primary outcomes

  1. Safety assessed by the incidence of adverse events, physical exam and lab-tests

    Time frame: for one year

Secondary outcomes

  1. Serum phosphate level

    Time frame: Baseline and 1, 2, 3, 6, 12 months after administration

  2. Serum calcium level

    Time frame: Baseline and 1, 2, 3, 6, 12 months after administration

  3. Intact PTH (parathyroid hormone) level

    Time frame: Baseline and 1, 2, 3, 6, 12 months after administration

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 17, 2013
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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