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OpenTrials
Completed

NCT Number: NCT01903213

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

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

Completed

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic 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

Chugoku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis

Treatment and study plan

bixalomer

Drug

Oral

Other names: Kiklin, ASP1585, AMG223, ILY101

Primary outcomes

  1. Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests

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

Secondary outcomes

  1. Serum phosphorous levels

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

  2. Serum albumin level

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

  3. Serum calcium level

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

  4. Serum 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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2013
Registry last updated
Oct 22, 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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