Skip to main content
OpenTrials
Completed

NCT Number: NCT00892749

Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease 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 Dialysis Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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 kidney disease patients on hemodialysis
  • Hyperphosphatemia
  • Written informed consent

Exclusion criteria

  • Patients with gastrointestinal surgery or enterectomy
  • Severe cardiac disease patients
  • Patients with severe constipation or diarrhea
  • Patients with a complication of malignant tumors
  • Patients with uncontrolled hypertension
  • Patients treated with parathyroid intervention

Treatment and study plan

ASP1585

Drug

oral

Other names: ILY101, AMG223

Primary outcomes

  1. Changes in serum Phosphorus level

    Time frame: After 48 weeks

Secondary outcomes

  1. Percent of the patients meeting the target range of serum Phosphorus levels

    Time frame: During the treatment

  2. Changes in serum Calcium level

    Time frame: After 48 weeks

  3. Changes in serum Ca x P

    Time frame: After 48 weeks

  4. Changes in intact PTH level

    Time frame: After 48 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase 3, Long-term Study in Patients With Chronic Kidney Disease (CKD) and Hyperphosphatemia on Hemodialysis

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 4, 2009
Registry last updated
May 4, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.