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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742585
• Other study ID #: 1585-CL-0101
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2012
• Last updated: July 15, 2014
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• ASP1585
oral
• placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in serum phosphorus level at the end of treatment		Baseline and Week 12 or treatment discontinuation	No
Secondary	Achievement rate of the target range of serum phosphorus level		During 12 week treatment	No
Secondary	Time to achieve the target range of serum phosphorus level		During 12 week treatment	No
Secondary	Time-course changes in serum phosphorus levels		During 12 week treatment	No
Secondary	Time-course changes in serum calcium levels		During 12 week treatment	No
Secondary	Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs		During 12 week treatment	No