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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017276
• Other study ID #: 1585-CL-0005
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2009
• Last updated: April 30, 2015
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: April 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 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, 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 Dialysis
• 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	Serum phosphorus level at treatment discontinuation		During the 12-week treatment period	No
Secondary	Percent of the patients meeting the target range of serum phosphorus levels		During treatment	No
Secondary	Time-course changes in serum calcium levels		During Treatment	No
Secondary	Changes in serum Ca x P		During Treatment	No
Secondary	Changes in intact PTH levels		During Treatment	No

External Links

•   Link to Results on JAPIC - enter 150710 in the JapicCTI-RNo. field (Japanese record)