Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Chronic Kidney Disease Clinical Trial

Official title:

ASP1585 Phase 3 Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742611
• Other study ID #: 1585-CL-0102
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2012
• Last updated: June 8, 2015
• Start date: March 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• 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 multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on dialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who completed study 1585-CL-0101 or new patients who meet following 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• ASP1585
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	Time-course changes in serum phosphorus levels		During 48 week treatment	No
Secondary	Achievement rate of the target range of serum phosphorus level		During 48 week treatment	No
Secondary	Time to achieve the target range of serum phosphorus level		During 48 week treatment	No
Secondary	Time-course changes in serum calcium levels		During 48 week treatment	No
Secondary	Time-course changes in serum intact PTH (parathyroid hormone) levels		During 48 week treatment	No
Secondary	Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs		During 48 week treatment	No