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NCT Number: NCT01742585

A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on 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 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

Chūbu, 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 (eGFR < 60 mL/min/1.73 m2)
  • Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl
  • 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 within 6 months

Treatment and study plan

ASP1585

Drug

oral

Other names: LY101, AMG223, bixalomer

Placebo

Drug

oral

Primary outcomes

  1. Change from baseline in serum phosphorus level at the end of treatment

    Time frame: Baseline and Week 12 or treatment discontinuation

Secondary outcomes

  1. Achievement rate of the target range of serum phosphorus level

    Time frame: During 12 week treatment

  2. Time to achieve the target range of serum phosphorus level

    Time frame: During 12 week treatment

  3. Time-course changes in serum phosphorus levels

    Time frame: During 12 week treatment

  4. Time-course changes in serum calcium levels

    Time frame: During 12 week treatment

  5. Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs

    Time frame: During 12 week treatment

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

ASP1585 Phase 3 Randomized Double Blind Placebo-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia Not on Dialysis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2012
Registry last updated
Jul 16, 2014

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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