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OpenTrials
Completed

NCT Number: NCT02805348

Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease

The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.

Completed

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Site JP00006, Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time

Treatment and study plan

bixalomer

Drug

Oral

Other names: ASP1585, AMG223, Kiklin, ILY101

Primary outcomes

  1. Change from baseline in the serum concentrations of phosphate

    Time frame: Baseline and up to Month 12

  2. Change from baseline in the corrected serum concentrations of calcium

    Time frame: Baseline and up to Month 12

  3. Change from baseline in the serum concentrations of intact parathyroid hormone

    Time frame: Baseline and up to Month 12

  4. Safety assessed by incidence of adverse events

    Time frame: Up to Month 12

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2016
Registry last updated
Oct 16, 2024

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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