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Completed

NCT Number: NCT01017276

A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis

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

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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

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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 peritoneal dialysis
  • Hyperphosphatemia
  • Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not changed within 28 days.
  • Written informed consent

Exclusion criteria

  • Patients with gastrointestinal surgery or enterectomy
  • Patients with severe cardiac diseases
  • Patients with severe constipation or diarrhea
  • Patients with a history or 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. Serum phosphorus level at treatment discontinuation

    Time frame: During the 12-week treatment period

Secondary outcomes

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

    Time frame: During treatment

  2. Time-course changes in serum calcium levels

    Time frame: During Treatment

  3. Changes in serum Ca x P

    Time frame: During Treatment

  4. Changes in intact PTH levels

    Time frame: During Treatment

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase 3 Study in Patients With Chronic Kidney Disease (CKD) With Hyperphosphatemia on Peritoneal Dialysis

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 20, 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.

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